Saturday, February 28, 2015

CHRONIC LYMPHOCYTIC LEUKEMIA

The dysfunction within the follicular center of the lymph nodes and the gathering swarm of functionally incompetent (anergic) self-reactive cells within the bone marrow produce poly-reactive autoantibodies creating Chronic Lymphocytic Leukemia (CLL).



CLL affects between 16,000 to 17,000 individuals mostly older ones with a median age of 58 years in the United States. Whites outrank other ethnic origins.

The CLL differentiated clusters of cells mostly include CD 19, CD20, C21, CD23 and CD5. Targeting the largest cohort is the latest game in therapeutics to suppress the wayward lymphocytic cell. Other Surface antigen markers are also listed in references.



·        Stage: From a prognostic point of view CLL had classically been staged based initially on Lymphocytosis. In the Rai model: Stage I: 25% Lymphocytosis. StageII: 50% Lymphocytosis with Nodes. Stage III: Stage II and Lymphocytosis with Nodes and Anemia Hgb less than 11g per deciliter and Platelets of  less than 100,000 per dL. 
Binet created a slightly better system anchoring on the values of Hemoglobin, nodes and platelets. Stage I = Hgb >10 g/dL, Platelets >100/dL and < 3 nodal regions involved. Stage II was essential Stage I with >3 Nodal regions involved. Stage III was Hgb <10g and="" or="" platelet="">3 Nodes. Favorable subsets emerged based on these gradations. However recent data has been able to disambiguate within the stages based upon the molecular nuances.



·         Chromosomal Data:
o   About 50% of CLL patients have 13q14 abnormality and are usually benign.
o   19% have 11q22-23 abnormality and are mostly aggressive
o   15% have 17p13 abnormality and have large nodal disease and aggression.

·         Molecular Data (Overexpression associated with lowering survivals):
o   ZAP70 (Zeta-associated Peptide of 70 kilodaltons) expression is associated with 8 year survival. ZAP70 non-expression CLL has >25 year survival.
o   CD38
o   IgVH (Immunoglobulin Variable Heavy Chain) (un-mutated) immunoglobulin gene. Interestingly high risk patients have low DNA mutation at the IgVH gene region and vice versa.
o   Bcl-2 (Down regulation of miRNA 15a and miRNA 16-1 increases Bcl-2)
o   Beta-2-Microglobulin
o   Lymphocytic doubling Time

·         Current Chemotherapy Regimens:
o   Chlorambucil
o   Fludarabine
Whereas Chlorambucil and Fludarabine PFS were identical at 18 and 19 months respectively, the Overall survival was 64 months and 46 months respectively, but it did not achieve significance.
o   Fludarabine(F) + Cyclophosphamide(C)
o   FC+Mitoxantrone or FCM
o   FC+ Rituxan or FCR

Adding Rituxan to FC improved the PFS significantly although the overall survival was not greatly impacted. It appears that monoclonal antibodies that target specific CD markers have short term increased responses but limited survival benefits. The escape velocity of this recurrence might suggest antibody production against the antibody being used in therapy, methods of dosing, or the CLL cells aggregating newer mutations over time. It is important to note that treatment of early CLL is not indicated as it is harmful through risk of infections and shortening of survival. CLL patients due to their inability to produce functional B humoral antibodies are not able to fight off bacterial infections.
o   CVP (Cyclophosphamide (C) + Vincristine (V or O) + Prednisone(P))
o   CHOP (H = Doxorubicin)
o   Revlimid (Thalidomide analog) was associated with 47% Responses and 9% Complete Remissions with complete elimination of Minimal Residual Disease MRD).

·         Monoclonal Antibodies and Cytolytics:
o   Rituxan (CD20 antibody)
o   Alemtuzumab (Anti CD 52) Effective against the aggressive 17p13 cases.
o   Ofatumumab (Anti CD 20)
o   Obinutumumab (Anti CD 20 cytolytic agent)
o   Ibrutinb (Bruton Tyrokinase Inhibitor) In a small number of cases with BTK mutation Ibrutinib is ineffective. In the RESONATE study Ibrutinib had a 58% response with a tripling of survival 24.2 vs. 5.5 months in previously treated patients.

Unfortunately what has plagued longer term survival is the existence of MRD following therapy. Comparing the newer agent Obinutumumab + Chlorambucil vs. Rituxan + Chlorambucil resulted in 78% vs. 65% Response, 27 months vs. 15 months PFS and the MRD in Blood was 37.7% vs. 3.3%, in the Bone Marrow MRD was 19.5% vs. 2.6%.  

·         Other Therapies:
o   Genetically modified T-Cell to express CD 19 used against CLL resulted in 26 of 59 patients with complete remissions (Proof of Concept study)
o   Allogeneic Bone Marrow Transplants: This therapy is the only known curative therapy known against CLL. It has an inherent risk of mortality as a consequence of the Induction and Conditioning related complications pre transplant and GVHD post-transplant. ABMT is utilized as an option in younger (50-65 years of age) patients with known molecularly determined aggressive disease who can withstand the rigors and risks of such therapy.
o   Duvelisib a dual PI3K gamma/delta inhibitor showed an impressive 98% nodal response noted on CT scan in 43 patients. This drug showed activity in 17p13 cases and at least one Ibrutinib refractory case.
o   Future pipeline include Anti-Bcl-2 drugs to enhance apoptosis in the errant lymphocytic population

Understanding the very nature of malignant biological diseases is the doubling time. A slow growing disease takes longer to accumulate cancer cells, thus the patient (host) survives longer with the disease. Also in most solid malignancies 2/3rds of the disease span is invisible and un-diagnosable due to malignant cell quantity as is depicted on the graphs posing variable doubling time. An aggressive disease grows faster and has a higher mortality lacking effective therapies. You can observe from this graph that the growth explosion occurs in the very late stages of the disease when it becomes (semi)resistant to therapy due to acquired DNA mutations and immune-surveillance blunting modalities.


Doubling
months
months
months
months
1
2
6
12
18
24
2
4
12
24
36
48
3
16
18
36
72
96
4
256
24
48
144
192
5
65536
30
60
288
384
6
4294967296
36
72
576
768

Will CLL yield to cure other than using ABMT?
Will multimodality therapies improve overall survival of each molecular subsets of the disease spectrum?

References:

 Shanshal, Mohammed; Haddad, Rami Y. (April 2012). "Chronic Lymphocytic Leukemia". Disease-a-Month 58 (4): 153–167. doi:10.1016/j.disamonth.2012.01.009.PMID 22449365.

 Jump up^ National Cancer Institute. "General Information About Chronic Lymphocytic Leukemia". Retrieved 2007-09-04.

 http://www.nature.com/leu/journal/v16/n2/full/2402363a.html#tbl4

Rai, KR; Sawitsky, A; Cronkite, EP; Chanana, AD; Levy, RN; Pasternack, BS (Aug 1975). "Clinical staging of chronic lymphocytic leukemia.". Blood 46 (2): 219–34.

Binet, JL; Auquier, A; Dighiero, G; Chastang, C; Piguet, H; Goasguen, J; Vaugier, G; Potron, G; Colona, P; Oberling, F; Thomas, M; Tchernia, G; Jacquillat, C; Boivin, P; Lesty, C; Duault, MT; Monconduit, M; Belabbes, S; Gremy, F (Jul 1, 1981). "A new prognostic classification of chronic lymphocytic leukemia derived from a multivariate survival analysis.".Cancer 48 (1): 198–206.
Shanafelt TD, Byrd JC, Call TG, Zent CS, Kay NE (2006).


Dohner H, Stilgenbauer S, Benner A, "" et al. (2000). "Genomic aberrations and survival in chronic lymphocytic leukemia". NEJM 343 (26): 1910–6 

Mraz, M.; Mraz, M.; Pospisilova, S.; Malinova, K.; Slapak, I.; Mayer, J. (2009). "MicroRNAs in chronic lymphocytic leukemia pathogenesis and disease subtypes".Leukemia & Lymphoma 50 (3): 506–509
 
Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, Albitar M, Brettman L, Santabarbara P, Wacker B, Rai KR (2002). "Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study". Blood99 (10): 3554–61. 
 
Urba WJ et al. (2011). "Redirecting T Cells". N. Engl. J. Med. 365 (8): 110810110014063 

Dreger P, Brand R, Hansz J, Milligan D, Corradini P, Finke J, Deliliers GL, Martino R, Russell N, Van Biezen A, Michallet M, Niederwieser D; Chronic Leukemia Working Party of the EBMT (2003). "Treatment-related mortality and graft-versus-leukemia activity after allogeneic stem cell transplantation for chronic lymphocytic leukemia using intensity-reduced conditioning". Leukemia 17 (5): 841–8. 

Thursday, February 19, 2015

"GIVE ME THAT MAN..."


Give me that man
That is not passion’s slave
Give me that blanket that comforts and soothes
For in my heart
There was a fighting that would not let me sleep,
Our indiscretion
Sometime serve us well.
In those wakeful moments’
When around a surgeon’s scalpel the blood congeals
And time is spent to heal.

What a piece of work is a man
The quintessence of dust.
What is he
Whose grief bears such emphasis
Such intricate complexity
Of thought and action?
How noble in reason
How infinite in faculties
To quell the cry of pain.

How like an angel
How express and admirable
To drown the misery
And purge the disquiet
Of a thousand natural shocks
That flesh is heir to
And to take arms against a sea of trouble
And by opposing, end them.

Yet within the firmament of that reason
I could be bounded in a nutshell
And count myself a king of infinite space,
Were it not that I have bad dreams.
These dreams, though this be madness
There is method in’t.
The vile mechanism feeds
And eyes without feeling
Feeling without sight,
Cannot chart the course to reason.

The spirit that I have seen, may be a devil
And the devil hath power t’assume a pleasing shape
Cleave the general ear with horrid speech,
Make mad the guilty and appal the free.
These clever studied orphans of untruth
Confound the ignorant and amaze
Indeed the very faculties of eyes and ears.
They forget in their charted hypocrisy;
This above all: to thine own self be true,
And it must follow, as the night the day,
Thou canst not then be false to any man.

The power that exudes such tyranny
Tis dangerous when the baser nature comes between
The pass and fell incensed points of mighty opposites.
They know not what they do
As their power is often fleeting
And the unholy madness, a passing fancy
A man may fish with the worm that hath eat of a king,
And eat of the fish that hath fed of that worm
They thus find permanence in indignity
within houses that last till doomsday.

While chastising nobility, they cry and
Humanity bleeds as one is lost to the many
Eviscerating the noble cause of individuality
The chief good and market of this time
Is left wanting in art and science,
Or somewhere in between.
This warlike paragon of animals
Abuses me to damn me.
As villainy though it have no tongue,
Will speak with most miraculous organ!
One day!

Leaving in its vile dust
This beauty of the world,
This noble of humans
This physician.
In apprehension how like a god,
I will wear him in my heart’s core,
Ay, in my heart of heart
As he grunts and sweats under the weary life
Bringing comfort through his discomfort

To the one of the many!

This poem is a composite of Shakespeare's eloquent words and some of mine. Juxtaposing with the Bard is tantamount to courting disaster, yet I will "screw my courage to the sticking place!"

Saturday, February 7, 2015

DICTATING the CURVE of a BANANA


Can you dictate the curve of a banana? Can you?



Quite naturally humans have faced threats of great magnitude and survived. They have the unseen instincts and intuition built into the mechanics of reason, which serve them well. The foreboding that comes with such intelligence is amplified via a magnificent brain design. All the peaks and valleys of the sulci and the gyri in the brain beautifully enfold these luxuries of scale in thought and action to prevent harm to self. When illness or a malady visits upon this “quintessence of dust,” there are doctors who stitch and heal the ripped fabric. Were it not for the doctors, human misery would be manifold, survival would still be languishing and the aging demographics would be a distant hope.

But now this enterprise of medicine largely folded into its doppelganger “healthcare” visits its Sister Souljah moment and everyone in the halls of power and control backs away from what was to how it must be. It must be “patient-centered,” they claim. “They are destroying healthcare!” they claim. But who is it that they point to?

That is where we lay our scene…

The Older Past…
Let us look back a few years to see what was. As a patient you went to see your doctor in his office and there were many such tiny little abodes where a single doctor and his army of one would take care of your malady. The doctor would spend time asking about aunt Melody and uncle Arthur and then delve into the rigor of extracting information about health and well-being. He or she would ask several questions about symptoms and signs that you might have observed or seen and any complicating side effects from the medicines previously prescribed and about any improvement in functionality. He would examine with his hands and use his stethoscope to listen to the inner murmurings of the body. Having satisfied himself to understand the problem fully he would pat the shoulders or she would give you a hug of comfort, a word of advice, a wink of understanding and walk with you to the exit. You felt when you left that you had just seen your best friend, most times.



The Old Past…
That lasted a while until the insurance industry and larger corporate types in the business world waddled in with their pendulous money-bags and gold watches tied to their belts. They created a mini-maze of bureaucracy through the HMOs and mandated a clear and unequivocal chain of command for how the doctor would be paid. There were the usual pre-approvals to reckon with, and authorizations to contend with. All in all the bureaucracy was carefully, through incrementalism, comfortably embedded in that tiny little Hobbit sized office. The doctor’s army of one increased to an army of four suddenly with the demands of those times. The doctors concerns about payroll of his employees and his capacity to maintain the level of service was at odds with the demands of the day. Other agencies came visiting and finding faults that had to be reckoned and made compliant, the enormously large volumes of mandates started taking its toll on the beleaguered physician. Now, as the patient entered the doctor’s office that had transformed from a small place to a modern facility of glass, steel and humming electronics, the doctor would say hello to the patient and then with his eye on his watch and one on the waiting room, where many sat fidgeting with their watches or hand bags delayed from their daily lives, sped through the complaints leaving behind a wrinkle of frustration on his or her patient’s brow. The hint of rush was felt within each conversation as interruptions every 18 seconds by the doctor to get to the bottom of the illness’s mystery was all he or she could care about. Time had become a precious commodity.



The New Present…
And if that was not enough, soon the Mack truck of full blown bureaucracy backed into the facility with tomes of “do this for that.” Failure to follow the legal jargon in those tomes, which said much in little, implied more than a lot and warned of a hellish future for noncompliance broke another rung in the ladder of “wellness” afforded to the patient.  There were computers humming in every room of these expanded facilities. The white coat became just that and no more. The doctor was busy looking at the computer as he asked perfunctory questions that were coded by an 18-year old software designer somewhere far away in some far off land to fulfill the desires of an insurer and its governmental agency that existed behind some heavily fortified impenetrable walls. The rush of the action and the patient’s laments were limited to yes and no while the truth of his malady remained entombed within. There was a rush and ruffle of papers handed to the patient and orders to get this and that done before the next visit. The diagnosis and therapy would have to wait until the results poured in later. The Ct scan would diagnose what the hands and critical thinking did before.
The expanded offices could not keep up with the demands of the verbiage. The doctors first tried to add to their staff, failing which they tried to formalize relationships with other doctors into larger networked groups so they could achieve survival through scale. As the demands increased and the rewards diminished many of these organizations failed to comport themselves to live within their contractual obligations. Other doctors left the Hobbit abodes and their expanded versions and sought refuge within the hospitals under the banner of 9-5 jobs.

The Newer Present…
There was a wrinkle on these greener pastures waiting to unfold. The hospitals now emboldened with their own doctor employees were no longer reliant on the community physicians. The hospitals now called the shots. The business-rooted CEOs up-coded their billings to increase their revenues and to increase their bottom lines as the business in the business of medicine slowly corrupted to the core. Meanwhile the CEOs, CMOs, and the CFOs enjoyed the windfall and all made handsome salaries in the 7 digits.  They preached “Do Less with More,” as they cut hospital staff to a minimum and exploited resources that would bring in the highest dollar. The employee-doctors were told how to code for their services, initially this was merely a suggestion and then through verbal force of threats of expulsion from the brotherhood of “providers,” it became the only game in town.  Meanwhile the patients barely saw the physician. The patient care was rapidly evaluated by other less educated individuals whose actions were rubber-stamped by higher authorities. Education was in full bloom, limit costs, abbreviate a trouble life and help a patient die well.



The Newest Present…
Ask your mother or your grandmother in how they perceived their interactions with their physicians then and now and a whole tale will unfold that might sound like a fairy tale. But you should ask, for there is wisdom in a long life! She will tell you that today it is the corrupted influence of inducement, incentivizing and threats that dehumanizes both the patient and the physician.

We are here… and it is today!
What the future holds is cloudy. I predict that once again the undying traits of liberty encoded within the human DNA. One day that small Hobbit-style office will spring back into action with or without the lust for the “global-public-good” decree. After all we are all patients and we will seek what sings to our souls. Patients will demand and the free-market will provide. We will have finally realized the lust to be like Europe! Yet ours will be different, it will not be due to the middling-many, the intermediaries. The favorable doctor-patient relationship will be achieved, through the individualism, liberty and dignity in the end. The old calling “Life Liberty and the Pursuit of Happiness” is also etched in our history’s 239-year old DNA.

No, I don’t believe that you can dictate the curve of a banana. Not just yet anyway! Maybe after sequencing a banana’s DNA we might find the gene that causes the bananas to curve and which can be knocked out to allow bananas to grow straight. Woe to us if we tamper with nature at that level just to prove a point!




Take note, fawners, facilitators and arbitrators!

Saturday, January 31, 2015

QUALITY METRICS, Probability & GOTCHA

Can the bounded asymmetry of thought align itself to the unbounded reality? That is the question. The premise is: "To drive progress, we are focusing on three strategies. The First is incentives, the Second, improving the way care is delivered and the Third, we aim to accelerate the availability of information to guide decision making through Meaningful Use of EMRs." ( here) The verbiage is enticing and any arguments to the contrary makes one look regressive, obstructionist and non-compliant! What could possibly go wrong if we were to reimburse physicians and hospitals for quality and withhold such payments for lack thereof?


Plenty!

First let me tell you up front about the “probability” function. A lot of it is based on assumptions. When we look at small samples and predict the event onto a larger population, there is always a chance that we will be wrong. As noted by John Ionnadis in his 2005 paper that 54% of all studies could not be validated due to the use/abuse of statistical modeling. Sampling has an inherent bias, even if we cite the Bayesian principle (which simply states that the probability of event B is the sum of the conditional probabilities of event B given that event A has or has not occurred). Here we are using conditional probability of independent events.

Here are a few assumptions:
1.       Patients with multiple (more than one) comorbid diseases have a higher chance of complications. eg: a) A diabetic patient with vascular disease and alcohol related fatty/cirrhotic liver has a higher chance of renal dysfunction. b) A neutropenic patient undergoing chemotherapy has a higher chance of infection with other complications related to the chemicals and biologics on top of other chronic conditions such as obesity, kidney disease, heart disease etc. c) An elderly patient with a coronary artery disease, previous myocardial infarctions has a higher chance of arrhythmia, congestive failure and pulmonary edema. 2 + 2 mostly ends up as 3 or 5 due to confounding factors mentioned above.

2.       Younger patients without comorbid diseases have better outcomes due to their resiliency from age. 2 + 2 indeed can amount to 4 in them. 

3.       The ratio of the healthy-young to elderly with comorbidities is roughly 3:1. This ratio is skewed, to the extent that the numbers vary regionally and community-wide and can be as low as 4:1 or as high as 2.25:1. A similar ratio feeds its way into the healthcare sector.

4.       Using those simple assumptions let us say that the following ACOs and hospitals exist: a) An ACO tied to a tertiary hospital. b) A rural hospital with limited resources. c) A multi-specialty group with a good reputation with privileges in a secondary hospital.

P = ( Probability # of successful hospital outcomes in total # of hospitals in a group)
# of successful hospital outcomes = x
Total # of hospitals in a group = n
Probability of making the successful outcomes = s
Our formula is: P= s^(x (1-s)^(n-x)

Let us look into the magic of probabilities and statistics. Assuming that the Probability of success in achieving the metrics mandated by CMS = 60% and the probability of missing the metrics is (1 – 60%) 40%. We then further assume that 8 out of the 14 hospitals will achieve this success or 14C8 (Out of 14 choose 8) which than gives us the combinatorial formula using factorization (14!/8!(14! – 8!) = 0.20 or 20%. We are giving higher potential of successful outcomes to a select number of hospitals (n=14) and saying that these hospitals had all the right kinds of resources and the right demographics of fewer patients with comorbidities. Then given all the risks and “paper-pushing-and-game-playing,” 8 out of 14 hospitals have indeed the potential of achieving probable success of 60%. The probability of that successful outcome happening is 20%, in other words even though we give this high likelihood of success, the potential probability of achieving that success is only 20%. OR putting it in numbers: The probability of NOT achieving success by these hospitals is ( 1- 20%) = 80%. (Or 80% of the time you are not going to get paid for services).



It is obvious for anyone to see that given the aging demographics of the United States and the retiring baby boomers that what the government keeps telling us suggests that the ratio will be even more skewed against the successful outcomes, unless humans become robots and an oil and lube job keeps them going until rust settles in from disuse.

Now let us take the first set of hospitals (here we take a larger sample n = 30) mentioned above and the ACO combinations:  a) Given the high risk nature of their patients the probability of achieving success in 15 of the 30 hospitals might dip to 40% hence the probability of successful outcomes goes down to 7.8%!



In the second scenario of rural hospitals (n =30) assume the probability of success is at 50% (the toss of a coin), the probability of successful outcomes now is 14.4%. The rural hospitals with a lesser number of complicated cases will have a better chance of achieving the successful outcome; almost double that of the tertiary hospital.



If you think that is questionable, just go back and review the P4P (Pay for Performance) plans conjured up in the dimly lit confines of the bureaucrats. P4P was abandoned as a result!

And with the third scenario, while it may appear good shows that the secondary hospitals and good reputation ACOs with a 70% probability of success in 15 of the 30 hospitals show a probability of successful outcome in 1.06%! 



So where does that leave us?

Actually it paints an interesting picture. Even if we were to double the successful outcomes probability in each case it would still be less than 50%. So here is where that leads us…

If less than 50% are able to play the game and get rewarded for it, then what happens to the rest who cannot? How many will survive without getting paid for services? Something to think about!

Remember the arcades where a quarter will get you a prize if you can steer the picker-upper claws to pick the prize from a large collection of soft teddy-bears and the like and drop it into the basket for you to collect. The only problem is that the picker-upper claws are loose and dangle as they slide over any of the colorful furry toy animals. So you spend and spend but never get a prize. The risk reward appears against the establishment, yet the truth is the consumer gets hosed into spending a lot more than the prize is worth and still never gets any.




We see the same gotcha thought process, only that a few will be able to manipulate their numbers to meet the required demands, but not for long. The evidence is plain to see when it comes to the ACOs how more than half of them shut down because they were unable to make any revenue to keep the doors open. Taking the lead from that concept what could possible go wrong to the entire healthcare system? The agenda to limit expense will be successful, to the extent that monies will not be doled out as mandates and checkpoints will guard the outflow. Success will be writ large in the obedient media. "Money has been saved!" will cry the headlines, and the demise of the scores of shuttered facilities will be ignored by the pundits. Yet with such outcomes the answer will also lie in the liberties of the human element. People who spend their lives acquiring knowledge to better their craft in caring for patients, I feel will find alternate sources of managing their patients and as Denials of Services (DoS) becomes the game du-jour, more patients will run away from the game. The bureaucrats will then come to the table, in order to keep their monopoly, by liberalizing the criteria and a new game will begin for the gullible.

So that leads me to another question. Is the attempt to make people (in this case doctors and hospitals) work to the bone but not claim any remuneration the underlying philosophy? Is hard work related reward now considered greed?  Times are a-changing! Aren't they?

What might happen if we look into the future further? Is the new model to create fewer entities that are able to “play the game” with the government mandates and the rest of the many to forfeit ability? Those that do play well will be glorified and those that don’t will be vilified. In the end the choices will narrow to a few. And with fewer vying for rewards comes better controls and less reasoned critical thinking.

Sounds harsh?

O' I imagine I will be skewered by some experts for being naive and a fool and I admit, I am both. But maybe constructive criticism will open a dialog and some eyes.

Think again! 

Wednesday, January 28, 2015

A SEA OF TROUBLES



Between the Wall and Bayonets
I derived that analogy from the old saying, “between a rock and a hard place.” In this case the Wall is not an unmoving stillness but like the front lines of the warriors of the past with shields advancing against a sea of arrows towards the bayonets. The bayonets are also mounted in the arms of the warriors hurtling in space on the backs of their steed collapsing the distance between.

Ah, in between those two movable targets sits the lonely physician. No, I want to make it clear this is not a boo hoo story of the poor physician. It is not and yet something tells me, it might be…read on.
“Choosing Wisely” as most of you might have heard is the latest version of a collective mindset that sits in the ivory tower and tries to control the mind and movement of the rational-decision-making-reason-based management advocates called doctors. What exactly is this “Choosing Wisely?” (www.Chossingwisely.org)



Ok folks gather around the camp fire and we can let our demons fly.

“Choosing Wisely” is purportedly an “Evidence Based Medicine” guideline format to spell out what supposedly works and what does not in the management of the patient. “The Choosing Wisely campaign was created by the ABIM Foundation to challenge medical specialty organizations to create a list of tests or procedures that can be used to "spark discussion" between patients and physicians regarding the utility of the tests.,, Choosing Wisely recommendations should not be used to establish coverage decisions or exclusions. Rather, they are meant to spur conversation about what is appropriate and necessary treatment. As each patient situation is unique, providers and patients should use the recommendations as guidelines to determine an appropriate treatment plan together.” That is what the ABIM Foundation pundits say. But upon further review as most have done, it appears to have other motives behind it. “Why 'Choosing Wisely' Won't Protect You in a Lawsuit.” William Sullivan, DO, JD points out that Section 5001(c) of the Deficit Reduction Act, the stated purpose of the list was to reduce healthcare expenditures under the Social Security Act.” And furthermore he states that “There are more than 2500 guidelines related to diseases and thousands more guidelines related to treatment of diseases, according to a review of the National Guideline Clearinghouse. Clinical practice guidelines may be used by either party in a medical malpractice lawsuit… It is therefore important to use clinical practice guidelines as outlines of general care that may change based on current medical research, and not as stringent datasets that necessarily define the standard of care.”

Herein we have another dilemma the lawyers can therefore successfully call these guidelines if you choose to follow as not the standards of care. Then we are left with, who will the jury believe, the articulate artist in the pinstripe suit or the fearful-chin-buried-in-the-neck doctor?

Here is another caveat that we as doctors may not realize, if the Insurance Company refuses to reimburse for services rendered outside of those that are considered “Chosen Wisely” and some harm was alleged, the lawyer can use the denial of payment as a testimony against good practice of medicine and sway the jury right or wrong against the physician. See how the wall moves towards the bayonets?



Moderate quality evidence is not something that doctors should consider hanging their hats on. Back pain is one of those that afflict a large majority of patients (about 19 million) and the American College of Physicians deems it unnecessary for physicians to do imaging in such cases. Yet 130,000 of patients have cancer and 1900 have spinal vertebral infections. If no X-Rays, CT scan or MRI are ordered, there is a missed diagnosis worth a few million to the plaintiff’s attorney. But here is the trap, articles abound suggesting that doctors order too many CT scans and expose their patients to radiation. There is no give in the opposing bayonets either.

To absolve themselves from any and all litigations related to these guidelines the ABIM foundation, the creators of the “Choosing Wisely” program have disclaimers: “The disclaimers contained in Choosing Wisely guidelines, such as "use of this report is at your own risk" and "the ABIM Foundation ... [is] not liable for any loss, injury, or other damage related to your use of this report…"

On the flip side of doing a test that was suggested as a moderate quality evidence that results in a some harm will automatically enhance the lawyers to seek out the experts from behind the ivory tower walls to shriek and yell as to the need for such a test on the patient thus burying the physician in a sea of troubles from whence he might not be able to practice medicine with reasoning. With one eye on the risk to patient and the other equally focused on “Choosing Wisely” guidelines. So, damned if you do and damned if you don’t! The implied volatility of support from “Choosing Wisely” is a double edged sword of Damocles. It hangs, terrifyingly, until it drops!


And now to the dried fruit approach of bashing the statistical proofs, which are abused in medicine, and draining the water out of them: the statistical methodologies used in scientific articles for majority of the “high impact” journals are unreliable and unverifiable, and bring little solace to the weary physician administering medical care (Ionnadis). When “Choosing Wisely” is based on the shaky foundations of some form of bias, hidden under the shifting sands of “Evidence Based Medicine,” then the rendered care to the vulnerable patient -based on any set of those guidelines is fraught with failure and impeachment.



There is a movement towards statutory guidelines that when followed will protect the physician from litigation. But then not following such guidelines based on physicians intuit and judgment will be subject to penalties and what of the best possible care for the patient?

The squeeze is on! Eat your Wheaties!

“Their understanding
Begins to swell and the approaching tide
Will shortly fill the reasonable shores
That now lie foul and muddy.”
-
Shakespeare


http://www.medscape.com/viewarticle/837399?src=wnl_edit_bom_weekly&uac=17589HT