This article does a great job bringing the elements of what created a complicated set of regulations for health care---and these regulations are tied with MAGNA CARTE and the beginning of Constitutional democracy in Europe, UK, and America. As is clear---in a democracy you have many divergent interests whose needs conflict with others and so over centuries----compromise has been made to accommodate especially WE THE PEOPLE.
When Republicans shout WE NEED TO STREAMLINE ALL THIS REGULATORY MESS-----they are saying we need to get rid of all the WE THE PEOPLE and just look at how to allow for-profit health systems maximize profits. That is why Clinton/Obama neo-liberals did with the Republican policy called the Affordable Care Act.----it deregulates in ways that will harm and kill citizens all to boost profit. ALL OF CONGRESS, STATE, AND LOCAL POLS ARE CLINTON NEO-LIBERALS AND BUSH NEO-CONS PUSHING THIS. So, Republicans are hyping their business-friendly voters to support breaking down centuries of WE THE PEOPLE protections most doctors tied to Hippocratic Oath---DO NOT HARM medicine support.
'THE LOGIC BEHIND REGULATORY COMPLEXITY
Is this complexity of health care regulation merely a result of a series of historical accidents and bureaucratic turf wars, or does it serve a purpose? The system’s intricacy may make it inefficient, but it actually fits quite well with the American temperament. It is driven by an interplay of competing forces that seek to have their interests represented'.
P T. 2008 Oct; 33(10): 607–608.
Why Is Health Care Regulation So Complex?
Robert I. Field, JD, MPH, PhD
Author information ► Copyright and License information ►
This article has been cited by other articles in PMC.The array of regulations that govern health care can seem overwhelming to people who work in the industry. Almost every aspect of the field is overseen by one regulatory body or another, and sometimes by several. Health care professionals may feel that they spend more time complying with rules that direct their work than actually doing the work itself.
The scope and complexity of health care regulation is the subject of a book that I recently published, entitled Health Care Regulation in America: Complexity, Confrontation and Compromise.1 With apologies for some admitted self-promotion, I’d like to summarize my conclusions, which may add a context for the topic.
My book describes an underlying logic behind the bewildering regulatory maze. The tangled web of health care regulation arises largely from a set of confrontations between opposing interests that created the system. Fortunately, an ongoing process of compromise keeps things in balance. To understand these forces is to appreciate why the complexity may actually serve a purpose.
Go to:THE NATURE OF HEALTH CARE REGULATION
The pervasive nature of health care regulation stems from the fundamental concerns that are at stake. Most observers acknowledge that some form of oversight is needed when factors as essential as life and health are involved. Even those who are especially suspicious of heavy-handed government bureaucracy see a public interest in some form of external supervision of this field. Policy debates, for the most part, swirl not around whether oversight should exist but, instead, around the way it should be structured.
However, the present regulatory structure is neither uniform nor consistent. A broad range of regulatory bodies and programs apply in different ways to various aspects of the industry. Health care regulations are developed and enforced by all levels of government—federal, state, and local—and also by a large assortment of private organizations. At times, they operate without coordination.
Go to:THE ORIGINS AND EXTENT OF COMPLEXITY
The origins of this complex system lie in a series of turf wars between opposing interests that have been waged in one form or another over the past 150 years. The contest between federal and state authority is enshrined in the federalist structure of American government, and the debates of today echo early disputes over which kinds of power should reside at each level. Most of the power to govern day-to-day activities resides with the states under the Constitution, but it is subject to pre-emption at the federal level when various enumerated concerns come into play, such as defense, foreign relations, and interstate commerce.
This division of control created a source of ongoing tension in health care oversight from the start. To take a longstanding example, basic oversight of many of the central players in the health care system, including physicians, hospitals, and insurance companies, is accomplished by agencies at the state level. In every case, however, it is coordinated by federal authorities. Similarly, most public health programs, including sanitation, restaurant inspections, and investigations of epidemics, are the responsibility of state and local regulators, but the federal Centers for Disease Control and Prevention (CDC) serves as an essential resource for collaboration on a national level.
Private regulators entered the scene in the early 20th century. The American Medical Association (AMA) sponsored the creation of a number of organizations that remain central today in the oversight of the medical profession, including those that accredit medical schools, administer licensure examinations, and certify specialists. These bodies supplement the work of governmental regulators. State medical boards, for example, use privately administered examinations in granting medical licenses, and the Medicare program relies on specialty certification as an indicator of physician quality. Along similar lines, the hospital industry accredits its own members as a supplemental step to state licensure through the Joint Commission (JCAHO).
Go to:THE REGULATORY MAZE: TWO EXAMPLES
As a result of this network of oversight bodies, those individuals and organizations subject to regulation must turn to multiple competing authorities for guidance. Two examples illustrate this dynamic.
The path to practicing medicine is paved with an array of regulatory hurdles implemented by an assortment of bureaucracies. A potential physician must attend a medical school that has received accreditation by a private body, take a national examination administered by another nongovernmental organization, obtain licensure from a state medical board, complete a hospital residency that is funded and governed by the federal Medicare program, achieve certification from a private specialty board, and obtain clinical privileges at a hospital that may operate as either a private or public entity. To receive payment for services and actually earn a living, it is often also necessary for a physician to qualify for participation in Medicare and in the network of a managed care organization (MCO).
The path to marketing a new drug is similarly cumbersome. A pharmaceutical company must start by protecting its invention with a patent that is issued by the federal Patent and Trademark Office (PTO). It must then receive permission to conduct clinical testing from the federal Food and Drug Administration (FDA), which for many products culminates in review of the results by an advisory committee composed of private scientists. After approval for marketing is received in the form of a New Drug Approval (NDA), the manufacturer must adhere to marketing restrictions contained in the NDA.
Next, in order to sell the drug widely, the manufacturer must obtain a place for it on the formularies of private pharmacy benefit management companies (PBMs), which administer reimbursement plans. Ideally, the drug will also be included in the standards of care promulgated by private medical specialty societies.
After all of these steps, the drug still cannot be sold unless it is prescribed by physicians and is dispensed by pharmacists who are subject to licensure and a range of other regulatory requirements.
Go to:THE LOGIC BEHIND REGULATORY COMPLEXITY
Is this complexity of health care regulation merely a result of a series of historical accidents and bureaucratic turf wars, or does it serve a purpose? The system’s intricacy may make it inefficient, but it actually fits quite well with the American temperament. It is driven by an interplay of competing forces that seek to have their interests represented.
Different levels of government vie with one another for supremacy, as they have since the founding of the republic. This system of checks and balances makes it less likely that any one level, federal or state, will become too powerful, and it ensures that the overall system will receive input from each. The regulatory structure also reflects a form of public–private partnership. Private organizations, such as the Joint Commission and medical specialty boards, which are composed of professionals who actually work in the field, inject technical expertise. These organizations are balanced by government agencies, which provide a more disinterested external perspective that is presumably less subject to economic self-interest.
In essence, the system benefits by receiving regulatory input from varying perspectives. State and local agencies are often closest to the actual provision of health care and the most sensitive to regional needs. Federal oversight is usually necessary to provide national coordination, for example, to prevent physicians who have been disciplined by a medical board from gaining licensure in another state. Private organizations offer the deepest expertise in the clinical aspects of care.
Go to:SYSTEM SHORTCOMINGS
This explanation is not meant to suggest that the system is without its share of shortcomings, because some of them are substantial. Critics charge that private regulatory bodies are often more interested in safeguarding the reputation and economic status of their industries and professions than in protecting the public. State regulators, particularly those in smaller jurisdictions, may be subject to excessive influence by those they are supposed to oversee. Federal agencies may be slow, bureaucratic, and inefficient.
Moreover, in some areas of regulation, the division of authority is not clearly outlined, a drawback that has led at times to chaotic results. A prime example is the oversight of health insurance. States take the lead in regulating insurance, but the federal government pre-empts some state authority over employer-sponsored health coverage under the Employee Retirement Income Security Act of 1974 (ERISA). The lines of responsibility are not clearly defined in the law, and they have been subject to a series of equally confusing court decisions.
Go to:CONSEQUENCES OF THE REGULATORY SYSTEM
Despite the complicated and inefficient nature of its oversight, American health care has flourished over the past hundred years. Rather than hindering its progress, the complex system of regulation, for all of its flaws, may actually have served to support and nurture the overall enterprise.
Consider, for example, the public confidence that is engendered in the competence of physicians through licensure requirements and in the safety and efficacy of prescription drugs through the FDA approval process. These programs enhanced overall respect for major elements of the health care system and greatly expanded markets for the goods and services that they provide. Regulatory programs that include major funding components, such as Medicare and research support administered by the National Institutes of Health (NIH), serve an additional role of creating a financial base for key sectors of the industry.
Viewing the system in this way may help to provide perspective for those who have to navigate it. It is also important to consider the underlying nature of the system, with both its positive and negative elements, in evaluating proposals for reform.
A more thorough presentation of the regulatory structure of the health care industry and the themes that drive it can be found in my book.
The very rich are writing these Affordable CAre Act policies and ACA will be tied to Trans Pacific Trade Pact policies making American health care on par with developing nations and that means killing all public interest and Hippocratic Oath history under the guise of HAVING TO BE COMPETITIVE WITH DEVELOPING NATIONS AND THEIR HEALTH CORPORATIONS.
Just a quick segue from last week's discussion on DARK AGES structures----in Medieval times surgeons were beneath Physicians because as working class-----working on commoners was beneath them. Physicians were the Ivy League university types tied to producing medical procedures and products and serving the rich. FLASH FORWARD TO TODAY----Obama and Clinton neo-liberals are building private university structures where corporate research and patenting comes from our universities----and heads of research departments are CEOs. They are getting rich in the product and procedure mill-----while our doctors are being made working class. These Ivy League research CEOs of today are often PHYSICIANS who became wealthy during the few decades of massive health industry frauds of our public Trusts Medicare and Meidcaid. I offended one of Johns Hopkins physicians when first moving to Baltimore by suggesting they VOLUNTEER for community health care----PHYSICIANS DO NOT VOLUNTEER AT JOHNS HOPKINS!
They are creating this same DARK AGES structure where are few richest are head of TRADE GUILDS with all other workers in an industry are working class feeling the push to ever-lower wages. This is why there is a mass exodus from being a doctor in the US -----as with teachers-----and it is why there is a mass movement of developing nation immigrant health care workers ----including doctors.
IVY LEAGUE UNIVERSITIES ARE BEING BUILT AS THE CORPORATE RESEARCH CENTERS WITH A FEW PHYSICIANS AS CEOs as American doctors are being made working class.
Medieval Medical Practitioners Physicians
Physicians were scholars who studied at universities. In order to be declared a physician, a student had to prove himself able to recite, lecture and debate the contents of his studies.
Surgeons belonged to the working class and did the jobs that were considered beneath physicians, such as bloodletting and pulling teeth. Most surgeries were performed by the barber/surgeon. The most common operations were for hernias, gallstones and cesarean section.
Whether retiring or fleeing, doctors are leaving health care
By R. Jan Gurley
March 27, 2014
In practical terms, we doctors are a fairly elderly bunch. Nationwide, despite churning out roughly 20,000 newly-minted medical school graduates a year, one in three doctors is over 50, and one in four is over 60.
One reason doctors are older than you think -- the training alone takes so many years. Or, as one uber-specialized colleague of mine said, “It’s hard to explain to your five-year-old son, without making him petrified to start kindergarten, that you’re actually in thirty-fifth grade.”
Knowing that one in four doctors will reach retirement age in five years is cause for enough concern. Then, there’s the well-documented doctor shortage coming down the pipe simply because not enough new doctors are being trained to meet the needs of the U.S. population. But do impending changes within the medical industry stand to drive doctors into early retirement? There’s evidence to indicate that it will.
In my previous post, I explained how Electronic Health Records (EHRs) have not materialized as the great panacea that would streamline and improve health care. Doctors have felt the weight of EHRs and are letting people know they are not happy, maybe even unhappy enough to leave the profession. During the Doccupy protest about the implementation of the EPIC EHR in Contra Costa County California’s safety net health system, a mass exodus was reported: “‘Six doctors have left this year,’ said Dr. Keith White, a 22-year pediatrician. ‘We were not ready for EPIC and EPIC was not ready for us,’ White told supervisors. ‘As a result, the providers are struggling to provide safe and effective care for 100,000 citizens of the county, many of whom are very ill. We often feel that we are failing. We are very tired ... many doctors have left and all are considering leaving.’” [emphasis mine]
Was this just one person’s exaggerated viewpoint?
Apparently not. Deloitte’s 2013 survey of over 20,000 physicians notes 62% say that “it is likely that many physicians will retire earlier than planned in the next one to three years. This perception is fairly uniform among all physicians, irrespective of age, gender, or medical specialty.”
And if they’re not retiring outright, doctors say they believe physicians will “scale back practice hours (55 percent) based on how the future of medicine is changing.” None of this is surprising when Deloitte reports that “[s]ix in 10 physicians (57 percent) say that the practice of medicine is in jeopardy.”
Retirement may be more of a problem in safety net systems, and in certain types of specialties, like primary care, where both the workload and the reimbursement rates are worse than other fields of medicine. But fleeing from a field with very high burnout rates is not unique to physicians.
Studies have shown that the idea of replacing primary care physicians with nurse practitioners has one fatal flaw - nurse practitioners, not surprisingly, burn out the same as physicians do when placed in high-stress positions. In the last year, I have personally seen an accelerated rate of both talented doctors and talented nurse practitioners retire early in safety net systems, rather than face the combined worsening workloads and impact of EHR rollouts on patient care.
Accelerated early retirement also leads to a critical mass effect: staff retire early, safety net positions are hard to fill, and the remaining smaller staff of providers tries to shoulder a now-even-more-expanded workload. A vicious downward spiral occurs with even faster burnout, more early retirements.
The fleeing of health care providers, especially in primary care and safety net systems, means that we are rapidly losing large chunks of irreplaceable workforce, even before the expansion of health care coverage occurs. Accelerating staff loss means that the remaining staff are even more at risk, as is patient safety.
How big are these combined effects? What does this mean for your community? Here are some questions for reporters to ask:
1) How vulnerable is your community? Take a brief survey of your safety net and primary care systems. How many of those providers - doctors and physicians assistants and nurse practitioners - are over 50? Over 60? Is it a larger or smaller proportion than the national average?
2) How fast is your system crumbling? How many people have retired in the last year? In the last two years?
3) How replaceable are the losses? Does your community start with an appropriate rate of primary care providers per capita, or not? How long does it take to fill a primary care position in your local system? Is the rate keeping up with the losses? What is being done if there is an issue?
4) How shaky is patient safety? What happens when a provider retires in your area and there’s no replacement? What are the patients’ stories? How many stories can you find of emergency care being necessary, or poor outcomes occurring, due to provider loss?
5) What about in other fields - like psychiatrists in safety net systems who care for the profoundly mentally ill, and whose EHRs are supposed to be even more onerous to use? What is their rate of staff loss, and how is patient/staff safety holding up?
6) Why are your local primary care and safety net providers leaving? Is there any exit interview process whose information you can access? If not - particularly for large health systems - why is no one doing exit interviews? You may want to find and interview providers who retired early. There could be a compelling story there. People who have left in crisis are often more willing to openly discuss the problems that led them to remove themselves from a health system.
SEE WHY THEY HAVE THE AMERICAN PEOPLE ONLY SHOUTING SINGLE-ISSUES----RATHER THAN EDUCATE ABOUT DISMANTLING TWO THOUSAND YEARS OF WESTERN CIVILIZATION'S MEDICAL ETHICS AND MORALITY.
When our medical schools become corporations and university medical research falling to facilities tied to these corporations-----you get the same corporate structure that existed in the DARK AGES-----Ivy League schools with a very few people from rich families will make up what are tenured positions-----including these connected to medical research---and these will be the university Physicians versus today's working class doctors.
This corporate university structure goes across degree categories---but Obama and Clinton neo-liberals created especially for Affordable CAre Act this structure in medical universities like Baltimore's Johns Hopkins and University of Maryland Medical Center. Along with it is the breakdown of all Federal regulations----from how Federal funding is used for research to how universities can select students and faculty-----to how they can skirt research protections in the rush to patent and get to market medical products and procedures.
Maryland Assembly and Baltimore City pols worked hard to deregulate Maryland health laws and passing laws to create these structures----sending all funding to these university research facilities.
Below you see corporate universities-----but medical universities are far more tied to Physician as university researcher-----vs doctors as working class Accountable Care Organization ( ACO) members.
Charts: When College Presidents Are Paid Like CEOs
As higher ed becomes more corporate, administrators' salaries are rising while their employees' are staying flat.—By Jaeah Lee and Maggie Severns
| Thu Sep. 5, 2013 5:00 AM EDT Mother Jones
It's been a tough few years for people working in higher ed: As the recession hit, pay for faculty stagnated, and schools have been struggling with budget cuts and the rising cost of providing education. There's one notable exception to this trend: Pay (and perks) for college presidents is on the rise. There are a lot of possibilities as to why this is happening, and none of them make the world of higher education look very good.
In the past, universities have made the case that incentives—often in the form of exit bonuses, deferred compensation, and loan forgiveness—are necessary to attract top talent, particularly highly skilled, and oftentimes high-profile, administrators. Yet some incentives simply cross the line, says Claire Potter, a professor at the New School who writes frequently about salaries for college administrators. Providing faculty with mortgages for homes is a common practice, she explains, but a few colleges have taken to forgiving those mortgages, essentially turning a loan into a cash payment. "There are two kinds of mortgages in play," Potter says. "One is the type that the university cosigns for you to get faculty in. The other is to give them a mortgage that essentially puts money in people's pockets."
Potter thinks the need to attract top talent is understandable, but within bounds. "As soon as you are getting extreme compensation at the expense of others, that's when it becomes a problem." Depending on the type of institution, between 2011 and 2012 a university president made about three times as much as a typical full-time professor at public schools. At private institutions, a president made about four times as much as a typical professor.
Part-time and adjunct professors, who make up a growing share of faculty, earn just a fraction of what executives make, at about $2,700 per course. A part-time professor with a master's degree teaching eight courses makes about $19,200 annually, according to a recent survey by the Coalition on the Academic Workforce. "Universities have so radically increased their use of part-time employees to do teaching and other services," says Cary Nelson, a former president of the American Association of University Professors who teaches at the University of Illinois at Urbana-Champaign. "Many of those people are simply no longer earning a living wage."
The number of presidents who make more than $1 million is also on the rise, and is no longer limited to private universities. As of this year, four presidents of public colleges are making more than $1 million, according to a Chronicle of Higher Education analysis.
Meanwhile, financial perks for executives are becoming more common and more extravagant. Nelson and Potter see a variety of factors contributing to this: For one, executive pay across many industries has risen sharply in recent years, and universities are run more like businesses than they were in the past. An underlying cause may be the composition of college boards of trustees, which are increasingly made up of high-powered individuals from the corporate world as opposed to a broader mix of alumni. In 2010, trustees with "business occupations"—including executives and administrators of a large corporation; a banking, financial, insurance, or real estate company; or a small business—made up about 42 percent of trustees at public university and 53 percent of those at private institutions, according to the Association of Governing Boards of Universities and Colleges.
"Often the trustees of universities are themselves CEOs," wrote the authors of a 2006 study in the Journal of Higher Education that looked at the potential influence of university trustees who also serve on corporate boards. "The salaries of CEOs have risen dramatically in the past decade. Where the networks of corporate directors and trustees are dense and overlapping, as CEO compensation in the corporate sector increases, a similar logic may well be applied to CEO compensation in private universities."
In 1994, the study's authors write, two private research university presidents made more than $500,000 (more than $788,000 in current dollars). By 2003, there were 42. While public institutions lag behind private ones—in 2004, 17 presidents of public research institutions were members of the "$500,000 Club"—they are likely to adopt similar practices over time. "The market for presidents spans private and public sectors, and so long as supplemental private resources are available, allows the publics to use private sector practices to leverage their boards for similar compensation packages."
As executive compensation packages become more lavish at some universities, it sets new standards for what's acceptable across the field, Nelson says. "You end up with a labor force in higher education that's very comparable to that of a corporation that is simply seeking to extract labor at the lowest possible cost. Is that the ethical model that higher education should emulate?"
1999 was Clinton era peak of moving US corporations overseas and that included health industry----PHARMA and Hospitals/Medical universities.
As you can see this article tells those small businesses in these developing nations that they will indeed by washed away by global corporations as has happened in the US. As important-----all of these US medical corporations and medical universities setting up in developing nations worked under developing nation conditions----THERE WAS NO RULE OF LAW, NO WESTERN WORLD HIPPOCRATIC OATH OR REGULATIONS TO PROTECT PUBLIC INTEREST.
This is what is now coming back to the US under Affordable Care Act deregulation. The new regulations allowing consolidation into global systems calling them Accountable CAre Organziations----or managed care.
No IRBs----internal review boards to make sure research is ethical and Constitutional ------no HIIPA requiring patients be informed and medical data confidential----no clinical trials to assure safety IN THESE DEVELOPING NATIONS WHERE AMERICAN HEALTH INDUSTRY HAS BEEN WORKING THESE FEW DECADES.
This is what Obama and Congressional neo-liberals did at the Federal level------and at the state assembly with state health system policy-----and at local level our pols deregulated and privatized and outsourced public health away....AND ALL OF THIS IS VERY, VERY VERY REPUBLICAN.
Below you see just an abstract of a great article showing how developing nations are now where much of the health industry growth is----and if you look at policies like Trans Pacific Trade Pact and International Economic Zone -----all you see is policy to break down a nation's public health structures----public subsidy of health care-----and lots of protections for PATENTS AND TECHNOLOGY. What is the current economic structures in Baltimore? Health industry tourism and telemedicine. None of these developing nations have a clue as to what rights of citizens are-----Rule of Law under Magna Carte WE THE PEOPLE WRITE LEGISLATION-----no thousands of years of medical ethics and regulations protecting public interest----
JUST WHAT INTERNATIONAL ECONOMIC ZONES WILL LOOK LIKE----AS IN BALTIMORE.
Health Res Policy Syst. 2012; 10: 18.
Published online 2012 Jun 6. doi: 10.1186/1478-4505-10-18
Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators
Rahim Rezaie,1,2 Anita M McGahan,3 Sarah E Frew,4 Abdallah S Daar,5 and Peter A Singer5
This study shows that while China, India, Brazil and South Africa vary in certain respects, entrepreneurs in each of these countries aspire to become innovative in biopharmaceuticals, and have made inroads against this objective. Regardless of geography, these entrepreneurs are affected by similar forces and often respond in analogous ways. There are important similarities in national approaches to: enhancing innovative capabilities, breaking down innovation barriers, financing innovative activities often through innovative business models, collaborating with international firms, profiting from intellectual property, and to facing global competition. The commonalities highlight that biopharmaceutical firms in the China, India, Brazil and South Africa are influenced by forces emanating, in part, from industry globalization. Consequently, their responses carry implications for the global industry as a whole.
Our research shows that the trajectories of companies in the developed and emerging economies are becoming increasingly intertwined. Few of the firms we studied planned on developing novel therapeutics for global consumption fully on their own because they do not have the necessary technical and financial resources and cannot tolerate the associated investment risks. As a result, promising leads in development within the emerging market firms will likely find a home within the pipelines of major global players, or be developed through collaborative arrangements with other firms. Enhanced innovative capabilities in the emerging markets, the associated cost arbitrage, and improved IP protection regimes are increasingly facilitating outsourcing of R&D activities from pharmaceutical MNCs to emerging market firms. Yet many of the companies we studied also aspired to global competitiveness within an element of the value chain. The new pattern that seems to be emerging is a globally disintegrated drug development value chain with greater participation of the emerging markets at different stages of activity. This is not to suggest that this evolution will reduce diversity in business models. Indeed the opposite is likely to be true as companies carve out specific niches within an expansive, global value-chain.
In summary, the ultimate outcome of each country’s collective activity is likely to be shaped as much by global factors as local conditions. It is exceedingly important to realize that success in biopharmaceutical innovation is about the hard work of adapting scientifically, nationally and globally all at the same time. The implication is that countries that can best understand this complexity and situate their own strengths vis-à-vis the broader global value chain will be most likely to achieve sustainable competitive advantage. It is also possible that the globalization of biopharmaceutical innovation will have deleterious effects on domestic industries in the emerging markets, and on access to health technologies in the developing world. Failure to sufficiently adapt to new realities could, for instance, lock emerging market firms into low-value segments of the innovation value chain for years to come, and/or limit their growth prospects by preventing access to new technologies. These areas deserve further study and continued vigilance to minimize adverse impacts on emerging market industries and pharmaceutical access.
Notwithstanding above observations, recent developments in the emerging markets have the potential to change the global drug development model itself, with a promise to making it more productive and accessible. It offers the possibility for more cost-effective innovations and significant impacts on health systems everywhere. Technological upgrading within many of the existing pharmaceutical manufacturers in the emerging markets is leading to a more competitive global pharmaceutical generics market – leading to lower drug prices. At the same time, we are witnessing the birth of a highly integrated global industry when it comes to innovation – promising greater therapeutic choice and lower drug development costs. In this respect, emerging markets with greater economies of scale, in terms of domestic market size, and the scope of capabilities built over time appear to be in an advantageous position. The implication is that smaller countries such as South Africa with more limited biopharmaceutical purchasing power and skill-base to build on appear to be at a disadvantage vis-à-vis China and India. Similarly, historical dominance of the state sector and a host of other institutional factors contribute to dampening Brazil’s potential when it comes to health technology innovation. On the whole however, greater involvement of the entrepreneurial sectors in the emerging markets in health innovation holds considerable promise for patients everywhere.
Below you see another American health regulation under attack----well, virtually ignored now----THE PRECAUTIONARY PRINCIPLE'
This is social democracy at its finest---it forces corporations away from profit at any cost----and makes social benefit work into the policy writing process. Market-based policy has eroded this over these few decades of neo-liberalism----but Trans Pacific Trade Pact will kill it outright.
'A Word in Favor of Reviving the Precautionary Principle
The time-honored Precautionary Principle says that an ethical business, governmental agency or culture should err on the side of caution before new chemicals, technologies, procedures, services, food additives, drugs, surgical procedures, etc are introduced into the marketplace (and the environment) – and only then should they be allowed on the market when there is absolute proof that the substances are not dangerous to the environment (which includes human/animal life, the water supply, the soil and the air – i.e., our fragile planet)'.
Is the Hippocratic Oath Being Killed off by the Big Business of Medicine?
by Gary G. Kohls / February 14th, 2014
When people ask me about what motivates me to occasionally blow the whistle on certain ethical issues, I sometimes say that I am just being true to the Hippocratic Oath that I took when I graduated from medical school. My 40 year medical career began as a board certified rural family physician and ended by practicing holistic mental health care for a decade. During that time I have often found myself, usually unconsciously, invoking the primum non nocere (latin for “first do no harm” ) standard while recommending a treatment for a patient. The Oath has served me well in medicine as well as in life, child-rearing, marriage and politics.
Following the ethical standards outlined in the Hippocratic Oath probably makes practicing modern medicine more challenging. In an era where deadly medicines (that are packaged in sub-lethal dosages) are being manufactured and marketed at an increasingly rapid pace by very powerful multinational pharmaceutical corporations that have seemingly unlimited resources to brain-wash us prescribers and our patients about their synthetic chemicals and the secrets of their laboratories, it is getting harder and harder to avoid doing harm to our patients.
The Big Business of Medicine seems to have decided that patients should be denied the time to relate all the pertinent details of their illnesses or to be able to ask all the pertinent questions they need to ask.
The Big Business of Medicine seems to have decreed that physicians should be denied the time to take comprehensive histories, thus impairing our ability make accurate diagnoses and plan curative therapies. Whoever is in charge of medical care delivery these days seems to have decided that physicians and nurses should be denied the time to do the thorough teaching required to be maximally effective discharging their duties, with the possibility, indeed the inevitability, of engaging in misdiagnoses and medical misadventures.
Just consider this simple fact: Trans-national drug companies that manufacture pharmaceutical drugs do not study the effects of drug combinations (of two or more drugs at a time) in the brains or organs of experimental animals – and the testing that is done on that single drug is usually only for an extremely brief period of time, often just hours, days or weeks. This is especially true for brain research.
That means that the physicians of the vast majority of drug-taking patients (especially the elderly who, studies say, swallow half a dozen or more pills per day) have no good scientific data that proves the safety or even mechanism of action of their regimen. That makes the swallowing of more than one such drug at a time a scientific crap shoot and an ethical dilemma for the doctor who has pledged to do no harm. Since there are no biopsy, radiology or immunoassay studies that tell neuroscientists and physicians whether or not any of the millions of possible drug combinations (or the billions or trillions of possible drug dosage combinations) are safe or even effective, the prescribing physician may be inadvertently doing harm to his or her unsuspecting patient when those untested combinations are prescribed.
And that goes for human clinical studies as well, where, in the case of psychotropic drug testing, patients-subjects of psychiatrists are tested with a single experimental drug for a relatively short period of time (usually just a couple of months or less), with no biopsy or radiological proof of long-term safety or efficacy before the FDA approves it (for long-term use). So again, patients who are prescribed more than one drug at a time have no scientific assurance of long-term safety or efficacy. Both those pre-marketing short-comings place the prescribing physician, unbeknownst to the patient, in an ethical bind.
And that is where the Hippocratic Oath should come in – if it still has any relevance in this age of modern medicine.
The Oath of Hippocrates is 2,500 years old and came out of ancient Greece. It is increasingly regarded by many, especially Big Business, pro-corporate types, as having limited applications to modern medicine. But if you ask patients who are concerned about the safety and effectiveness of their drugs, they regard the “never do harm to anyone” ethic as still being relevant to them and their children, even if Big Business has decreed otherwise.
Immediately below is an English translation of the Oath. Note that dietary treatment is the first regimen mentioned in the oath, which underlines what Hippocrates is often quoted as having said, namely, that “food is medicine and the best medicine is the best food”. Also note the underlined portions, especially the line that condemns deadly medicines.
The Oath of Hippocrates
I swear by Apollo, the healer, Ascelepius, Hygieia and Panacea, I take to witness all the gods, all the goddesses, to keep according to my ability and my judgment, the following Oath and agreement:
To consider dear to me, as my parents, him who taught me this art; to live in common with him and, if necessary, to share my goods with him; To look upon his children as my own brothers, to teach them this art; and that by my teaching, I will impart a knowledge of this art to my own sons, and to my teacher’s sons, and to disciples bound by an indenture and oath according to the medical laws, and no others.
I will prescribe dietetic regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.
I will give no deadly medicine to any one if asked, nor suggest any such counsel; and similarly I will not give a woman a pessary to cause an abortion,
But I will preserve the purity of my life and my arts.
I will not cut for stone [“cut for stone” means “to operate on bladder stones”], even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this area.
In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or men, be they free or slaves.
All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal.
If I keep this oath faithfully, may I enjoy my life and practise my art, respected by all humanity and in all times; but if I swerve from it or violate it, may the reverse be my life.
Non-physicians do not pledge the Hippocratic Oath when they complete their studies, although some paramedical educational institutions have adapted portions of it for their purposes. Some nursing schools, for instance, have their graduates take a pledge called the Nightingale Pledge (which was written in the 1890s in honor of Florence Nightingale, the founder of modern nursing. Nightingale gained international fame for her efforts on behalf of wounded, sickened and malnourished soldiers during the disastrous British military misadventure in the Crimea in the 1850s). Here is one version of the Nightingale Pledge:
The Nightingale Pledge
I solemnly pledge myself before God and in the presence of this assembly, to pass my life in purity and to practice my profession faithfully.
I will abstain from whatever is deleterious and mischievous, and will not take or knowingly administer any harmful drug.
I will do all in my power to maintain and elevate the standard of my profession, and will hold in confidence all personal matters committed to my keeping and all family affairs coming to my knowledge in the practice of my calling.
With loyalty will I endeavor to aid the physician, in his work, and devote myself to the welfare of those committed to my care.
Is the Hippocratic Oath Obsolete, Overlooked or Just Killed Off?
Most of us took the Hippocratic Oath seriously in the early stages of our medical careers, but after getting into the “real world” of high-productivity medicine, most of us had no choice but to gradually compromise our ideals because of 1) the need sign on with a well-administered clinic; 2) the need to be maximally productive (seeing as many patients as possible in the shortest period of time) in order to pay off our $100,000+ medical education debt; 3) the need to stop trying to do all the time-consuming things that patients expect and deserve; 4) the need to get most of our continuing medical education credits from courses subsidized by the pharmaceutical industry; 5) being seduced almost daily by the pharmaceutical industry’s very attractive opposite-sex sales reps, bearing gifts of “pens, pizzas and post-it notes” in their drug company’s efforts to get us to uncritically adopt, as the new “community standard of care”, the extensive use of potentially toxic synthetic chemicals not yet proven to be safe long-term, especially when combinations of these always very expensive drugs are used.
It is often said that the real clinical trials of new drugs start when the brief pre-marketing studies — involving only hundreds or occasionally thousands of test subjects — have been approved by the FDA, for that is when millions of unsuspecting, but excited patients get their first prescriptions of the latest wannabe blockbuster drug that they saw presented so appealingly on TV.
Big Business argues that the profitability of business enterprises depends on getting new products into the marketplace quickly in order to generate profits as soon as possible. Thus, paying for thorough, independent long-term studies (especially with watchdog agency oversight) is only grudgingly accepted by the profit-driven investors on Wall Street.
Should Capitalism’s Doctrine of “Letting the Buyer Beware” Apply to Patients as Well?
In light of the current corporate reality of profit maximization (and that goes for HMOs, hospitals and most clinics, especially the for-profit kinds with their multimillionaire CEOs), we physicians should be the ones who make sure that no harm is being done because of the drugs we prescribe. Throughout history, physicians have always accepted, as a sacred trust, the duty to warn patients about the potential dangers of their treatments, and there are many. (For more on iatrogenic diseases (doctor or medical treatment-caused), see Dr. Barbara Starfield’s article in the July 26, 2000 issue of the JAMA documenting the annual 225,000 iatrogenic deaths per year in the US; also see Iatrogenesis.)
In order for a patient to give fully informed consent to a treatment option, he or she must be given thorough information about the risks, safety and efficacy of the treatment both short-term and long-term, which, in the case of most psychiatric drugs, is virtually impossible to do given the lack of long-term studies that were done prior to FDA approval and the poor post-marketing surveillance that is done. Medical malpractice suits commonly revolve around the issue of adequate informed consent.
Patients deserve to know whether or not psychotropic drugs are addicting or dependency-inducing, are capable of causing withdrawal symptoms or whether or not the patient can be sickened or intoxicated by the drugs. Patients also deserve to know about the existence alternative therapies which, in the case of mental health issues, utilize good psychotherapy and nutritionally-based, life-style alterations, approaches that are often falsely discredited by medical trade association groups like the AMA, the APA and their medical journals. The giant multinational corporations that generously fund such groups, are always looking for ways to eliminate the competition in order to achieve a near-monopoly for the sale of their substances.
A Word in Favor of Reviving the Precautionary Principle
The time-honored Precautionary Principle says that an ethical business, governmental agency or culture should err on the side of caution before new chemicals, technologies, procedures, services, food additives, drugs, surgical procedures, etc are introduced into the marketplace (and the environment) – and only then should they be allowed on the market when there is absolute proof that the substances are not dangerous to the environment (which includes human/animal life, the water supply, the soil and the air – i.e., our fragile planet).
So when medical industries wish to market new synthetic chemical substances that have the potential to adversely affect human or environmental health (even years or decades into the future) the Precautionary Principle requires that adequate and aggressive long-term studies (funded by agencies totally independent of those who want to profit from the substance) be undertaken and then only approved when it has been proven to be totally safe.
So, under the Precautionary Principle, regulatory agencies must be given permission to aggressively withhold the marketing approval of potentially carcinogenic, disease-producing, neurotoxic or immune system-destroying products from the environment from where they may be ingested, inhaled or otherwise absorbed into the bodies of potential victims.
Therefore, before potentially dangerous substances are allowed onto the grocery store shelves or into our pharmacies, hospitals, clinics and then, inevitably, into our bodies, the Precautionary Principle says that they should be first proven that they will do no harm, short-term or long-term.
As was documented in last week’s Duty to Warn column America has a drug-induced dementia, suicide, violence and mental ill health epidemic on its hands that should be obvious to every critical thinker that looks at the evidence. But because there are not many in the medical professions with the time (or willingness) to look at the evidence, the epidemic will surely continue to worsen because of the continued chronic use of non-curative drugs that are, in America, too often used as first-line “treatment”. Both psychiatric drug-induced brain disruption and psychiatric drug withdrawal syndromes can be mistaken for mental illnesses of unknown cause.
We can do better for our patients — and our dying planet — if we just go back to the honorable past traditions exemplified in the Hippocratic Oath and the Precautionary Principle.