Sunday, August 5, 2012

ISM/FoSiM: The irrelevance of more "Science" in Healthcare Reform

ISM (Institute of Science in Medicine) and their Australian "mini-me", FoSiM (Friends of Science in Medicine), are advocating a rather extreme version of Healthcare reform:
Medicalisation of all Healthcare, under the guise of advancing "Science in Medicine".
These extreme views are published in an ISM Policy paper on the Licensing of non-Medical Healthcare practitioners. They advocate changing world-wide statues/regulation to only allow "science-based" Healthcare (code for Only Medical Care) and finish with:
Unscientific practices in health care should further be targets of aggressive prosecution by regulatory authorities. [italics added]
They don't just want to wind the clock back to The Grand Old Days of the Fifties, but a whole Century. The authority they cite is the 1910 Carnegie Foundation report on Medical Education by Flexner.

Flexner tossed around a bunch of concepts, many more than the State Regulation of Medicine and Medical Schools on which ISM/FoSiM base their calls for increased Healthcare Regulation, a.k.a. "Science in Medicine", as the definitive solution to all the ills of all Healthcare Systems in the world.

In the second half of this piece, Flexner's original thesis and concepts are examined - and not wholly surprisingly they support the opposite position of ISM/FoSiM.

Firstly, What do the world's best experts in Healthcare Reform identify as the local and/or common challenges to Healthcare?

And, How do the proposals of ISM/FoSiM address these Medical Millennium Challenges?

Dr Brent James, executive director of Research and Quality at Intermountain HealthCare, Utah, (IHI) has extensively published hard data on Quality Improvement in Medicine, won prestigious Quality and Medical awards and co-authored landmark works on Patient Safety, Quality of Care and delivery of Best Practice Medicine. After 3 decades of implementing and executing successful reform programs at IHI, Dr James easily qualifies as one of the experts on Healthcare Reform.

Dr James, in his initial slides for his Advanced Training Program, ["Managing Clinical Processes: Doing Well by Doing Good"], lays out a lot of diverse material that underpins his Quality Improvement methodology and forms a consistent, well-formed theory driving his decades of successful Reform, not like ISM/FoSiM, a set of untested Ideological assertions.

On Slide 9, "Total health: How long, how well we live", Dr James lays out what the Evidence says on the contributors to Good Health. They are:
  • 40% - Behaviour under control of the Individual (loosely, 'lifestyle choices'). Tobacco, Alcohol, Movement Deficit Disorder [humour!]
  • 30% - Genetics
  • 20% - Environment and Public Health
  • 10% - Health care Delivery (Hospitals and Clinics)
On the next slide (10), "The Great Equation", he states [with sources cited]:
  • Health = medical care and medical care = "access to care"
  • "But the Great Equation is wrong ..."
And then goes into a lot of detail about why that is so.

In slide 29, "Dr. John Wennberg", he describes Wennberg's research/analysis:
  • Geography is destiny ("Who you see is what you get")
  • There is no health care "system"
  • Supplier-induced demand: [many examples follow]
In slide 31, "Care-associated injuries in hospitals", Dr James describes one of the primary source of waste in Medical care, which he addressed at IHI, providing net savings of 20-32% in delivering services. Not to mention much better Patient outcomes.
  • Injuries drive direct health care costs totalling $9 - 15 billion per year [Thomas et al. 1999, Johnson et al. 1992]
Dr James is also quoted in a forum organised by his University, PANEL ON HEALTH CARE REFORM – FALL 2008, Continuum, Utah University.

This is what he has to say on the Challenges facing Healthcare around the world:
JAMES: Another point is that we’re getting exactly what we pay for. We tend to pay for procedures and rescue care, so we get lots of procedures and lots of rescue care. This is a key factor.
Another thing you need to know is that other countries have exactly the same problems. So don’t look for solutions in Europe. Don’t look for solutions in Canada.
I get a ton of those guys coming through visiting to see how care’s delivered in Utah, believe it or not, because they face exactly the same problems.
There’s a standard working list of the top five problems within health care, and nobody’s solved them.
Travel the world and it’s the same list of five things:
1. The first problem is variation in care on a geographic basis.
It’s so high that it’s impossible that all Americans are getting good care, even with full access.
2. The second biggest problem is high rates of care directly judged to be inappropriate.
This is where the medical risk treatment outweighed any potential benefit to the patient and we did it anyway . . . usually in a rescue setting.
3. The third problem is unacceptable rates of care-associated injury and death.
This is where the care delivered actively killed somebody, whose death was judged to be preventable upon review.
4. The fourth problem is that the system does it right only 55 percent of the time.
There are things that we know for a fact should be done every time but the system does right only 55 percent of the time.
Now, that’s better than zero, but it’s not nearly 95 percent or 98 percent, where it ought to be.
5. And the last one is that there’s at least 50 percent waste in the system.
This is non- value-adding from a patient’s perspective, and that’s where the opportunity exists.


From the hard-data evidence presented by Dr James based on more than 3 decades of successful Healthcare Reform, we know:
  • The ISM/FoSiM proposals address the least important, least useful areas of change. 
  • Addressing Lifestyle Issues and Environment/Public Health would have six times the impact of attempting to improve "Health Care Delivery" through more "Science".  
    • Even then, ISM/FoSiM are either vague or silent on just what benefits their proposals, if adopted, can deliver. If they want to turn Healthcare around the world inside out, with considerable disruption, cost and upheaval, then they need to first inform us of the exact benefits we can expect.
  • The ISM/FoSiM proposals are irrelevant to the common "Top 5" Challenges faced by Healthcare Systems around the world: None benefit from more "Science", they are all about Quality of Care and Effectiveness of Delivery and Implementation.
  • All successful and effective Healthcare Reform, since and including Flexner, has been Patient-centric. The ISM/FoSiM proposals aren't just wrong, but exactly the opposite of what is documented to have worked. Practitioner- and Profession-centric reforms, such as "More Science in Medicine" do not deliver better outcomes for Patients.
ISM/FoSiM consistently demand high-quality Evidence and rigorous Science from those in its sights, yet fail to apply the Scientific Method and their Rules of Evidence to their own proposals and assertions.

To be consistent and credible, ISM/FoSiM must:
  • Meet the same standards of "Evidence", Research and adherence to the Scientific Method as they demand of others.
  • Demonstrate and Quantify how more "Science" will improve Quality of Care, Patient Safety, Equity of Access and Systemic Waste and Cost-Effectiveness issues identified as "Top 5" Healthcare Reform Challenges by the leading experts in the field.
  • First define their own "Top 5" Healthcare Challenges, and
  • provide research backed by verifiable, hard-data on the Efficacy of their own proposals, their own favourite criticism of non-Medical Healthcare.
If ISM/FoSiM criticise the Effectiveness of non-Medical Healthcare, we must in turn ask them to demonstrate the Effectiveness of their own proposals. If they set Rules and Standards for others, they need to follow them themselves, even better, demonstrate by superior example.

The Flexner report doesn't just say "Regulation and Licensing is necessary" as ISM/FoSiM seems to think, it also says many things still relevant today:
  • it asks for common standards and basic clinical education with laboratory practice,
  • suggests the 'Best Practices' as used by the Europeans,
  • says that Medicine is a Performance Discipline [my words] - that Theory and Practice/Experience together are needed by competent Professionals ("Head and Hands"),
  • that Medicine is not primarily a commercial enterprise, but has a very large "Public Service" component, with a Duty of Care not just to individuals treated, but the larger Community,
  • and explicitly recognises "all medical sects", and they be based on good clinical education.
It also contains an implicit commentary that demands:
  • As part of good Professional conduct, the systematic elimination of Known Errors, Faults and Failures, ("To Err is Human", but repeating preventable mistakes is malpractice of the highest order) and
  • From the Flexner principle of "licenses bear a uniform value":
    • Continuing certification retesting of all license holders, not a lifetime grant of license.
    • the adoption of practices that have been demonstrated to have value in assuring Professional competence and skills/knowledge currency at every point in time for all license holders. From Aviation, we know these techniques work:
      • Frequent (2 monthly) "Check Pilot" assessment of the in-situ performance of every Practitioner,
      • Simulator checks of "worst-case" situations. (Quarterly)
Why would we expect Medicine to have lower Quality and Practitioner Certification standards and processes than other fields? Heatlhcare should be the leader in Practice Efficacy, Quality, Safety and Cost-Effectiveness.

Flexner and the Carnegie Foundation were critical of the medical profession, its standards and ethics of practice: what we'd now call 'governance'.

They also called for the general public to be trained in assessing doctors and requiring professional practice from them. Something not included in the ISM/FoSiM proposals.

The report also emphasises that all medical professions owe a Duty of Care to their patients which requires much higher standards that other work:
it is a 'public service' on which people trust their lives, not merely a business.
Today, Flexner and the Carnegie Foundation might phrase their argument in terms of "Quality of Care", "Patient Safety" and whole system effectiveness, not just single element "efficacy".
By professional patriotism amongst medical men I mean that sort of regard for the honor of the profession and that sense of responsibility for its efficiency which will enable a member of that profession to rise above the consideration of personal or of professional gain.
As Bacon truly wrote, "Every man owes a duty to his profession," and in no profession is this obligation more clear than in that of the modern physician.
Perhaps in no other of the great professions does one find greater discrepancies between the ideals of those who represent it.
The interests of the general public have been so generally lost sight of in this matter that the public has in large measure forgot that it has any interests to protect.
Flexner notes the importance of the basic Professional Charter: It's professional malpractice to repeat or allow, Known Errors, Faults and Failures.
"There the Clinical professor comes in to the Aid of Speculation and demonstrates the Truth of Theory by Facts,"
he declared in words that a century and a half later still warrant repetition;
"he meets his pupils at stated times in the Hospital, and when a case presents adapted to his purpose,
he asks all those Questions which lead to a certain knowledge of the Disease and parts Affected;
and if the Disease baffles the power of Art and the Patient falls a Sacrifice to it,
he then brings his Knowledge to the Test,
and fixes Honour or discredit on his Reputation by exposing all the Morbid parts to View,
and Demonstrates by what means it produced Death,
and if perchance he finds something unexpected,
which Betrays an Error in Judgement,
he like a great and good man immediately acknowledges the mistake,
and, for the benefit of survivors, points out other methods by which it might have been more happily treated."" [ An essay on The Utility of Clinical Lectures, by Thomas Bond, 1766.]
The writer of these sensible words fitly became our first professor of clinical medicine,1 with unobstructed access to the one hundred and thirty patients then in the hospital wards.
Flexner rather strongly states that "Medical Care" goes much further than treating diseases/conditions presented to the surgery, a position that would make him outside today's AMA:
The overwhelming importance of preventive medicine, sanitation, and public health indicates that in modern life the medical profession is an organ differentiated by society for its own highest purposes, not a business to be exploited by individuals according to their own fancy.
Flexner advocates for reform and states categorically the underlying drivers - that Patient-centric, not Practitioner- or Profession-centric solutions and specifically not intransigent Ideologies are required:
The public interest is then paramount, and when public interest, professional ideals, and sound educational procedure concur in the recommendation of the same policy, the time is surely ripe for decisive action.
Flexner specifically notes:
  • that mere Science, 'the instrumental basis of medical education', is woefully inadequate for a good Practitioner.
  • that physicians must be much more broadly trained and well-rounded individuals.
  • and they their education starts with their graduation, not finishes.
Just how was that to be done isn't said in that section. [Or at all?]

This non-disease view of Flexner and the Carnegie Foundation on Preventative Medicine and treating communities, not just individuals, is wildly at odds with the prevailing medical paradigm and the polemic of ISM/FoSiM...
The practitioner deals with facts of two categories.
Chemistry, physics, biology enable him to apprehend one set;
he needs a different apperceptive and appreciative apparatus to deal with other, more subtle elements.
Specific preparation is in this direction much more difficult;
one must rely for the requisite insight and sympathy on a varied and enlarging cultural experience.
Such enlargement of the physician's horizon is otherwise important, for scientific progress has greatly modified his ethical responsibility.
His relation was formerly to his patient - at most to his patient's family; and it was almost altogether remedial.
The patient had something the matter with him; the doctor was called in to cure it.
Payment of a fee ended the transaction.
But the physician's function is fast becoming social and preventive, rather than individual and curative.
Upon him society relies to ascertain, and through measures essentially educational to enforce, the conditions that prevent disease and make positively for physical and moral well-being.
It goes without saying that this type of doctor is first of all an educated man.
Flexner often uses the phrase "scientific medicine", but what did he mean?

This was 15 years before Karl Popper's theory of Falsifiability and more than 6 decades before the current notion of "Evidence Based Medicine" rose from the 1972 paper by Cochrane and Sacket's 1996 definition of the term.

Flexner left us a definition, even emphasising that arrogance and dogmatic insistence on "One Truth" is anathema to the Scientific Method:
The modern point of view may be restated as follows:
medicine is a discipline, in which the effort is made to use knowledge procured in various ways in order to effect certain practical ends. [italics added]
It is precisely the function of scientific method - in social life, politics, engineering, medicine - to get rid of such hindrances to clear thought and effective action.
Science believes slowly; in the absence of crucial demonstration its mien is humble, its hold is light. [italics added]
"One should not teach dogmas; on the contrary, every utterance must be put to the proof.
One should not train disciples but form observers: one must teach and work in the spirit of natural science." [Johannes Orth: Berliner Klinische Wochenschrift, vol.xliii. p.818]
Flexner lays out the philosophical basis of his recommended Medical Education system, based on the Scientific Method. He specifically addressed Education in "Medical Sects" (e.g. Homeopathy and Osteopathy) - as good a name as the ISM/FoSiM term "CAM" (Complementary and Alternative Medicine).

ISM/FoSiM don't just ignore that Universities now teach "CAM" courses according to Flexner's requirements, rather the reverse, they have called for the banning of exactly those courses.
The logical position of medical sectarians to-day is self-contradictory.
They have practically accepted the curriculum as it has been worked out on the scientific basis.
They teach pathology, bacteriology, clinical microscopy.
They are thereby committed to the scientific method ; for they aim to train the student to ascertain and interpret facts in the accepted scientific manner.
He may even learn his sciences in the same laboratory as the non-sectarian.
But scientific method cannot be limited to the first half of medical education.
The same method, the same attitude of mind, must consistently permeate the entire process.
To emphasise the point, Flexner wrote about acceptable education of non-Medical practitioners, defining objective tests based on process, not Ideology and preconception.

Substitute "Medical Sect" for "CAM" and Flexner defines for ISM/FoSiM the requirements that are now met by University courses:
Sectarians, in the logical sense above discussed, are
(1) the homeopathists,
(2) the eclectics,
(3) the physiomedicals,
(4) the osteopaths.
All of them accept in theory, at least, the same fundamental basis. 
They admit that anatomy, pathology, bacteriology, physiology, must form the foundation of a medical education, to use the words broadly so as to include all varieties of therapeutic procedure.
They offer no alternative to pathology or physiology; there is, they concede, only one proper science of the structure of the human body, of the abnormal growths that afflict it.
So far, they make no issue as against scientific medicine. [italics added]
Much is involved in agreement up to this point.
The standards of admission to the medical school, the facilities which the schools must furnish in order effectively to teach the fundamental branches, are the same for all alike.
A student of homeopathy or of osteopathy needs to be just as intelligent and mature as a student of scientific medicine;
and he is no easier to teach; for during the first and second years, at least, he is supposed to be doing precisely the same things.
At the beginning of the clinical years, the sectarian interposes his special principle.
But educationally, the conditions he needs thenceforth do not materially differ from those needed by consistently scientific medicine.
Once more, whatever the arbitrary peculiarity of the treatment to be followed,
the student cannot be trained to recognize clinical conditions,
to distinguish between different clinical conditions,
or to follow out a line of treatment,
except in the ways previously described in dealing with scientific medicine. [italics added]
He must see patients and must follow their progress, so as to discover what results take place in consequence of the specific measures employed.
A sectarian institution, being a school in which students are trained to do particular things, needs the same resources and facilities on the clinical side as a school of scientific medicine. [italics added]
Flexner showed, like ISM/FoSiM, an innate dislike for, and bias against "non-Medical" Healthcare Professions, but very clearly defined a set of Professional Principles that, if complied with, would him to accept the practice of any Medical Sect.

Instead of an authority against "CAM" as ISM/FoSiM suppose, Flexner definitively supports non-Medical Healthcare, if its Education process meets his requirements:
The law may require that all practitioners of the healing art comply with a rigidly enforced preliminary educational standard;
that every school possess the requisite facilities;
that every licensed physician demonstrate a practical knowledge of the body and its affections.
To these terms no reasonable person can object;
the good sense of society can enforce them upon reasonable and unreasonable alike.
From medical sects that can live on these conditions, the public will suffer little more harm than it is destined to suffer anyhow from the necessary incompleteness of human knowledge and the necessary defects of human skill.
On Medical Boards and Regulation, Flexner wrote they needed legislative power, and unlike ISM/FoSiM, did not conflate his report recommendations with the political lobbying needed to implement them. He also continues to underline the importance to the Profession of Public Duty.

There is another powerful, central principle of Flexner's: Medical Practitioners are not 'free agents', they first owe a duty of Public Service.
The power that validates the diploma with its license must have the strength to protect its issues against either debasement or infringement.
The physician, like the lawyer, is an agent of the state. [italics added]
If he proves unworthy, the same board that vouched for him must have power to recall its act; and its function must extend to the prosecution of fraudulent or unwarranted attempts to practise without its official sanction.
The state must therefore provide funds that will enable the board to defend its action in the courts.
A model state board law must therefore guard the following points:
  • the membership of the board must be drawn from the best elements of the profession, including - not, as now, prohibiting - those engaged in teaching;
  • the board must be armed with the authority and machinery to institute practical examinations, to refuse recognition to unfit schools, and to insist upon such preliminary educational standards as the state's own educational system warrants;
  • finally, it must be provided either by appropriation or by greatly increased fees with funds adequate to perform efficiently the functions for which it was created.
The additional powers needed in order to deal as effectively with the practice of medicine, lie outside the present discussion. [italics added]
Flexner lays out more criteria for Regulation/Licensing of the Medical Profession, including a criteria who's implications have not been explored by the Regulators, nor mentioned by ISM/FoSiM: for licenses to have uniform value, they cannot be issued for life, frequent certification retesting is necessary.

If that premise is accepted, then it also demands the Regulation/Licensing process itself cannot be static. It must be continually examined, refreshed and updated with new Knowledge as it becomes available. As has been done for decades in Aviation.
The creation of separate boards is thus a roundabout method of recommitting the errors that the main currents of scientific thinking and effort are endeavoring to remedy.
A single board should subject all candidates, of whatever school, to the same tests at every point.
The license of the state is a guarantee of knowledge, education, and skill.
The layman is in no position to make allowances.
The state's M.D. and the state's D.O. offer themselves for essentially the same purposes.
The state stands equally as guarantor of both.
No citizen can indeed be wholly protected by the state against his own ignorance, fanaticism, or folly.
[referring to a previous comment: men who don't "believe" in doctors can't be forced into treatment]
The state is powerless there.
But having undertaken to vise practising physicians for the protection of those who summon them, it must see to it that the licenses to which it gives currency bear a fairly uniform value. [Italics added]
In conclusion, Flexner talks of Duties, Ethics and the need of the Medical Profession to guard against the corrupting effects of commerce. Exactly the same "Conflict of Interest" message that Arnold Relman and Marcia Angell started writing about in the New England Journal of Medicine in 1980.
Like the army, the police, or the social worker, the medical profession is supported for a benign, not a selfish, for a protective, not an exploiting, purpose.
The knell of the exploiting doctor has been sounded, just as the day of the freebooter and the soldier of fortune has passed away.
It's fitting to end with a quote from Arnold Relman ("A Drumbeat on Profit Takers"):
“It’s clear that if we go on practicing medicine the way we are now, we’re headed for disaster.”
If the things the best and brightest minds in the world of Medical Science are writing, researching and talking about, and have been doing so for 3 decades, are completely different to what ISM/FoSiM started advocating in 2009, then who should we give credence to?

My vote goes to the existing experts who can provide hard-data to back their stories, not mere puffery, exaggeration and "spin" as offered by ISM/FoSiM.

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