Life Science Compliance Update

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35 posts from March 2010

March 31, 2010

Doctors are Well Able to Tell Science From Hype - A Minnesota Prespective

Stephen F. Hodgson, MD a Mayo Clinic endocrinologist in an editorial published in the Rochester Post-Bulletin argued that physicians are able to make their own judgments and against legislation introduced in Minnesota basically banning interaction between physicians and industry. 

Bellow is the editorial in its entirety:

Rep. Tina Liebling's three bills, recently before the Minnesota Legislature (House Files 1640, 1641, 0491), include an attempt to take control of the information physicians receive concerning new drugs and medical devices, under the rationalization that physicians are duped into prescribing medical products that are unnecessary and expensive, and that medical care costs can be reduced by circumventing marketing pressures.

Rep. Liebling states that physicians are coerced by marketing techniques whose influences are so subtle that physicians can't recognize them, and that this creates a "conflict of interest" that erodes patient trust and drives up medical costs.

These legislative efforts ratchet up restrictions that prohibit marketing inducements felt to be corrupting to the weak-minded among us. No clear evidence is presented that a real systemic problem exists, or that previously enacted legislation has produced any reduction in the cost of medical products.

In her comments in the Post-Bulletin (see "Both Sides: We must limit influence of drug companies") Congresswoman Liebling implies that there is a subtle culture of corruption among Minnesota physicians, who actually are in all likelihood the most ethical and dedicated single group of individuals in the state. How could our Legislature so badly misunderstand the nature of the commitment that Minnesota's physicians have to their patients?

All physicians are trained to weigh scientific data and are well able to distinguish between science and hype. They are trained to use evidence — based information, to asses the quality of the data, to make clinical decisions accordingly, and to place the needs and interests of their patients first.

They are fully aware that pharmaceutical and medical device companies want them to prescribe their products but also know that all information transmitted from industry is, by law, required to be accurate and to conform to specific wording, and is regulated and approved by the Food and Drug Administration.

"Conflicts of interest," a term Rep. Leibling and others use to stigmatize normal overlapping interests, are a constant feature of every relationship, whether it's a physician receiving information from a pharmaceutical company or receiving a fee from a patient, a politician taking campaign contributions from a constituent or the tort bar, an academic medical center pandering to the Legislature on which it is dependent for funding, or an uninformed and biased reporter trying to satisfy reader interest or editorial goals.

Physicians recognize that overlapping interests derive from a multiplicity of incentives, often involve real and potential motivational differences and are an inevitable aspect of human interaction in all walks of life. More importantly, they know how to make appropriate decisions in this environment on behalf of their patients. To try to legislate conflicts of interest out of existence, though in keeping with an increasingly intrusive governmental regulatory zeal, is regressive and clearly illustrates the ultimate futility of government control over human thought and interaction. To attempt to legislate restrictions of this nature may also be a violation of the First Amendment to the Constitution.

The facts – evidence based – are that patients' trust in their physicians remains high and has not changed in spite of political and journalistic attempts to undermine it. Furthermore, a study by economist Dr. Frank Lichtenberg of Columbia University, carried out over two decades in 52 counties and controlled for demographic, social, and economic conditions, showed that new drug launches accounted for 40 percent — five months of every year — of the increased longevity observed over the period of study.

When we consider that human longevity has increased from 47 to 78 years over the past century, we cannot escape the conclusion that new drugs have played a major role.

Another roadblock in the process won't benefit anyone, and laundering information through academic medical centers like the University of Minnesota only introduces another set of biases and conflicts of interest to the equation, and slows access to new and effective products.

Rep. Leibling seems to conclude that new drugs and devices are too expensive and therefore are unnecessary, and assigns therapeutic decisions to a faceless government-appointed formulary committee that will never be able to asses the individual needs of patients. In fact, approved new medical products only exist because they are useful and sometimes lifesaving. In the long run, this short-sighted legislation will do harm to our patients by denying or delaying the availability of new drugs and medical devices and limiting the treatment options that patients and physicians can consider. In addition, the bureaucracy it establishes will only add to the cost of government.

Before another layer of intrusive legislation is enacted, it is reasonable for citizens to demand objective evidence that previously enacted legislation has unequivocally reduced costs or produced value, and that all legislation that does not meet its own objectives be rescinded. '

I urge Rep. Leibling, her colleagues, and those who support this legislation to let physicians do their job, and to seek real and effective ways to reduce the cost of medical care. For example, have our legislators considered the obvious money saving benefits of tort reform, or is the "conflict of interest" between the tort bar and politicians just too compelling?

March 30, 2010

CMSS Response to IOM – Perhaps No Need for Redesigning Continuing Education in the Health Professions

In response to the Institute of Medicine’s recently published report titled “Redesigning Continuing Education in the Health Professions”, the Council of Medical Specialty Societies (CMSS) asserted that a Continuing Education Institute accountable to the federal government is unnecessary.

In asserting their position CMSS, which represents 32 major medical specialty societies with an aggregate membership of more than 580,000 physicians in the US, noted the organization could not support the new proposed institute for various concerns.

CMSS acknowledged that the IOM’s report, which used “five broad messages,” made no mention of two recent innovative developments in continuing medical education (CME), Point of Care CME (POCCME) and Performance Improvement CME (PICME). Instituted in 2005 these two new forms of CME are beginning to revolutionize the lifelong learning of physicians.

As CMSS describes, POCCME takes place when a physician is confronted with a question about the management of a patient currently receiving care. The physician accesses an evidencebased source, either live on the internet or downloaded, then armed with the new knowledge implements a change in his/her practice behavior toward that patient, which is linked by evidence to improved patient outcomes.

PICME, as defined by the American Medical Association, is an activity that is a “structured, longterm process by which a physician or group of physicians can learn about specific performance measures, retrospectively assess their practice, apply these measures prospectively over a useful interval, and reevaluate their performance.” Physicians review their current practice, engage in learning activities to improve practice based upon nationally accepted performance measures and then reevaluate their practice to assess improvement. Repeating this procedure regularly creates a “Culture of Improvement” in practice. Currently, more than a dozen medical specialties offer PICME, with more programs in development.

CMSS also pointed out that the IOM incorrectly states the role of “pharmaceutical and medical device companies in financing the provision of and research on CE.” The reality is, “accredited CME providers determine CME programming through needs assessment, and produce CME under recently revised criteria.” Moreover, data from the Accreditation Council on Continuing Medical Education (ACCME) reveal that less than half of financial support of CME comes from commercial support.

Another problem with the IOM report is that it does not recognize that certification requirements were recently standardized by the American Board of Medical Specialties in March of 2009. Moreover, the Federation of State Medical Boards recently released for public comment its report on proposals for Maintenance of Licensure through state medical boards.

In addition, the report does not consider the importance of the Conjoint Committee on Continuing Medical Education (CCCME), convened by CMSS in 2002, with the original charge to “reposition” CME. In 2009, CCCME adopted the goal of using the CME system to improve the performance of the US health system, as measured by international benchmarks (such as World Health Organization measures). To do so, three strategies were proposed:

-    The integration of performance improvement into CME;

-    Consideration of the development of curricula for CME, at the system, specialty and practice levels; and

-    Convening the national dialogue on the financing of CME to assure the absence of influence of commercial support on the content of CME


As evidenced by all the concerns from CMSS, it is clear that the IOM committee has not recognized, nor taken into consideration significant recent changes in the accreditation and delivery of continuing medical education, as well as its use by certifying and licensing boards. In fact, the report did not fully consider the Standards for Commercial Support: Standards to Ensure the Independence of Continuing Medical Education, which were revised and promulgated by the ACCME in 2004, with enforcement strengthened in 2008. These standards have been adopted by all three accreditors of CME in the US (ACCME, AOA, AAFP) and by all three CME credit systems (AMA PRA, AOA, and AAFP).

Accordingly, because the report lacked evidence and a vision, the recommendation for an Institute for Continuing Education which is either accountable to, or managed by, the federal government is unwarranted. CMSS recognizes that the profession of medicine is accepting responsibility for transparent, voluntary selfregulation of continuing medical education in many ways not reflected in the IOM report. The profession is actively accepting accountability for its part in facilitating the evolution of lifelong learning for physicians, with the goal of measurably improving patient outcomes, through facilitation of a new culture of improvement in medical practice.

Consequently, we agree with CMSS that the profession of medicine should be responsible for professional voluntary selfregulation of continuing professional education, not governmental regulation. Ultimately, “continuing education is a professional responsibility, and one in which the profession is leading.”

The Erosion of Private Physician Practices

Just as the Obama Administration added 31 million to an already overworked and understaffed health care system, the New York Times noted a “quiet revolution” occurring in America that is transforming how medical care is delivered in this country. The impact of this ‘revolution’ “could have a big impact on that law’s chances for success.”

For example, “an increasing share of young physicians, burdened by medical school debts and seeking regular hours, is deciding against opening private practices.” This kind of trend could be extremely harmful to patients who seek doctors, and would only add to the crowded waiting rooms. As a result of this trend, doctors are now accepting salaries at hospitals and health systems, and older doctors — “facing rising costs and fearing they will not be able to recruit junior partners — are selling their practices and moving into salaried jobs, too.”


One only has to look at the numbers: since 2005, the share of medical practices that were physician owned dropped from nearly 80% to just below 50 percent, “and analysts say the slide has continued. Consequently, it could mean that patients see bigger health care organizations that can provide better, more coordinated care, or it could mean patients lose their close relationships with a longstanding doctor. The shift to bigger health care providers is more likely a sign that private health insurance is going to get more expensive for individuals.

Adding to this price increase is the fact that the new health care legislation provides for bundled payments for certain kinds of medical care, which “may further speed the decline of the private-practice doctor and the growth of Big Medicine.” Another issue forcing doctors from private practice is their growing concerns over medical errors and changes in government payments to doctors. The Times noted that “an even bigger push may be coming from electronic health records” (EHRs).

The problem with EHRs is that they are “expensive and time-consuming for doctors, and their substantial benefits to patient safety, quality of care and system efficiency accrue almost entirely to large organizations, not small ones.” Since the economic stimulus plan last year included $20 billion to spur the introduction of electronic health records, older doctors are moving away from private practice to avoid this burden.

For example, Dr. Gordon Hughes, chairman of the board of trustees for the Indiana State Medical Association, noted that “young people coming out of training now don’t want to do much and don’t want the risk of buying into a practice.”

This lack of private practices is disheartening for patients who are used to seeing the same doctor every visit because Big Medicine does not have the same consistency. Moving to a bigger organized health system that tries to push for quality may “put health insurance out of reach for much of the middle class.”

For example, Dr. Michael Mirro of Fort Wayne, Ind., a 61-year-old cardiologist, is among 22 cardiologists, who used to work in one of the largest private heart clinics in Indiana. "But in December, Dr. Mirro and his partners sold everything to Parkview Health, a growing health system that owns the hospital across the street from their building.” The reason for the sale was because they “had to hire more and more people to contact insurers and advocate for people to get the care they needed.”

This trend has been seen across the country for cardiology practices that have been selling out to health systems or hospitals. In fact, Dr. Jack Lewin, chief executive of the American College of Cardiology, estimated that the share of cardiologists working in private practice had dropped by half in the past year. Even more troublesome, Dr. Lewin noted that the remainder of those left are looking to move in that direction, with or without reform passing.”

In the end, if “patient-centered” care is what Congress passed, having a different doctor for every visit seems to be far from ideal.   Many of the changes adopted by congress in the health care package such as limiting imaging self referral, yearly valuation of practices and reporting the value, will only speed up forcing physicians to sell their practices.

Accordingly, Congress should look at ways to save private practice is and own up on its promise to ensure that patients are able to continue seeing their doctors.   


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