Sunday, December 20, 2015


It occurred to me, as it might have to scores of others in the legion of medical care that there is something very disturbing going on. Now before we get ourselves in bunches, let me say, this only affects the physicians in very meaningful ways. (There, I’ve lost the majority of the readers). For those still hanging on, lets look at what is exactly going on.
Remember the Electronic Medical Records (heretofore mentioned as EMR or EHR interchangeably)? I’m sure you do. But here is the rub, When the powers that be, all comfortably seated in deep cushioned chairs on marbled floors designed the concept, they failed to understand the basic patient-physician interaction. After all their paradigm was based on the ICD and IPT coding mechanics buried within a sea of paper data within the vaults of the Centers for Medicare and Medicaid Services (heretofore called CMS). The digits when subjected to the rigors of algorithms would displace all worries. So using their best or only information, they (the powers to be) deduced that if all information could be inputted by the physicians directly into the digital format, why, then the CMS could make meaningful decisions, such as appropriate payments for services rendered. Rampant in that thought process like dust scattering from an ailing fantasy was the concept of cost-containment. After all the cost of healthcare was going up and usurping 18% of the Gross Domestic Product. “That could not be!” they cried. So the EMR “Meaningful Use” was invented. Some coddled the green fantasy as well, “Less paper invoice use would save the trees!” Nothing better than that, sliced bread, apple pie and gaia-hood all packaged in one.

The carrot placed upon the dying breed of physicians who really cared for their patients was, “If you implement an EMR in your medical practice, CMS would give you “X” amount of dollars. Doctors felt, “Hey why not. I get to digitize my medical records and have them available 24/7 to me for decision making.” A win-win concept they thought. “Everything on my little smartphone or tablet.” Not so fast, you graphene-loving-silicone-dependent gadget lovers, not so fast.

Along came an enterprising agency with the best ceramic wafers, bestowed as “the EMR provider” by the CMS, whose CEO had paid a significant amount of money in election campaigns, and won nearly half if not more of the software/hardware installations across the global field of healthcare in the United States. But the software was proprietary and therefore not easily, if at all interactive, with other software vendors vying for the same multi-billion-dollar pie (not in the sky). The doctor’s records could not interface with the hospital medical records nor with other physician’s and lo and behold silos developed within the software empires where dollars were raining down by the bushels. from millions into billions overnight, just like the tech-boom of 1999.

Physicians, oh yes lets not forget those “middlemen” as some called them, were stuck with thousands of out of pocket dollars in purchasing, implementing, training employees and themselves, losing hundreds if not thousands of hours that should have rightly been spent in caring for their patients. The reward after expensing a large supposedly reimbursable “X” amount from CMS they were shocked to realize that of they paid $30,000.00 for a system and $10,000 for implementation, the reimbursement was around $16,000.00 - $18,000.00. But, hey the Return on Investment would be the speedy reimbursement from CMS that would take a bite out of the Medical Revenue Cycle, and that, the physicians thought was worth the loss they were incurring. The only caveat was if you were tied to medicare for reimbursement for services rendered and you did not dive into the EMR business you would face a cut in payments also.

Not so fast Watson, CMS decided to implement the ICD-10 coding system and told physicians to take a loan for keeping themselves afloat during the governmental transition and delayed payments. Oh okay, but everything would be alright afterwards. No worries!

The stick followed the carrot in lock-step. And as we all know accepting money from a governmental agency is filled with a stack of papers that have to be signed, boxes to be checked, “Ts” crossed and “Is” dotted. The next hammer was a Medicare (CMS) Audit of all the physicians who had claimed the EMR bonuses. If the use was not “Meaningful” in the auditor’s opinion then doctor would have to return the bonus back to CMS. Oh and by the way, the auditors were outside agencies empowered to go and find out those that had not complied and these auditors for their efforts were to receive 20-30% of the returned bonus bounty. This might sound sarcastic, but the incentive for the auditors makes them slightly porous to the wild idea of “dinging” the doctors (agency theory) to improve their own bottom line (hey that’s human nature -  don’t blame me, I’s just pointing it out to you).
Meanwhile studies started tumbling down the express corridor that “EMR Meaningful Use” had not improved medical care for the patient at all. In fact patients began complaining (as if anyone was listening to them in the bureaucratic stronghold of CMS) that the doctor spent more time looking at the computer screen then at them. The doctors ambushed with costs, audits, denials of service, patient dissatisfaction, became disillusioned and depressed (over 54% if not more). They were told that their expertise was subpar to the algorithm based on some wide eyed, bushy-tailed 18-year old software engineer and may not based on decades of experiential reference. Oh no, the codes told the story and treatment had to be based on the codes or the rain of sparking embers from CMS would engulf the physicians into a spectacular conflagration. Care would be based on Costs from now on and more and more Societies and expert physician bodies mirrored the meme of this rapidly unfolding paradigm. 

The story goes on…

The fingers keep pointing at the patient - physician interaction and at the physicians. In one breath Healthcare costs ($3 TRILLION) are tied to care delivered by the physician to his or her patient. No where is mentioned the 800lb businessman/woman gorilla that loves to ransack the honey-ladened spread under the tent.     

Don’t get me wrong, there are a few bad (apples) physicians and other providers in the healthcare field that give a bad name to us all. But they are few and can be weeded out easily without destroying the best medical care in the world.

The answer… cometh soon.

Wednesday, December 16, 2015


Lung cancer is the second most common cancer in both women and men, eclipsed only by breast cancer in women and prostate cancer in men. ACS estimates 221,200 cases in 2015 with 158,040 related cancer deaths. It accounts for 13% of all cancer occurrences and 27% of all deaths related to cancer. Early diagnosis and treatment meets with cures although only 15% of the NSCLC are diagnosed early.

NSCLC treatment has mostly revolved around, surgery, radiation therapy and chemotherapy for the longest time. The marginal successes have had little impact on overall survival. Today the era of Molecular medicine hopes to change that paradigm.

Non Small Cell Lung Cancers are grouped into Adenocarcinoma (50%), Squamous Cell (30%) and Others (20%). Each subset carries its own characteristics of genetic mutations, although overlap is commonly seen amongst the groups.

Common known Mutations in Adenocarcinoma: 

  1. Epidermal Growth Factor Receptor (EGFR) is the most common one and is present in 50% of the Asian patients and 10% in the non-Asians.
  2. KRAS mutations in 25% of cases are less common among smokers and absent in Asians.
  3. ALK and EML4 fusion is present in 2-7% of the NSCLC (mostly adenocarcinoma) non-smoker patients.

Targeted Inhibitors designed to target these molecular structures include:

  1.              Erlotinib and Geftinb are most effective in cases with exon 19 deletion, exon 21 L858R, and exon 18 G719X. The Pan-Asia study showed a 9.6 months survival in gefitinib-treated patients, versus a 41% ORR with a median duration of response of 5.5 months for the carboplatin/paclitaxel chemotherapy group. (Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010 Jun 24. 362 (25):2380-8). However resistance is noted after one year of therapy with these Kinase Inhibitors. A specific mutation noted at the exon 20 T790M is found in the resistant cell lines. these mutations have been targeted effectively with another Inhibitor Afatinib with modest success. In the LUX-Lung Trial, results showed the Afatinib group’s progression-free survival (PFS) was 11.1 months compared with 6.9 months for those treated with pemetrexed/cisplatin chemotherapy regimen. (Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, et al. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations. J Clin Oncol. 2013 Jul 1)
  2.          However Cetuximab a monoclonal antibody to EGFR noted to have activity in NSCLC (adenocarcinoma) without the EGFR mutation, later a post hoc analysis revealed that the EGFR mutation status conferred a better response rate.
  3.          For patients with ALK mutations Crizotinib and Ceritinib have modest efficacy. Trilas showed response rates of approximately 50% to 60% with crizotinib. Response duration was 42-48 weeks. (Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010 Oct 28. 363(18):1693-703). (Shaw AT, Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Mar 27. 370(13):1189-97).

In (Squamous Cell Cancer or SCC) NSCLC The demonstrated impact of molecular targeting is less clear since the targets have as yet to be clearly defined. in about 5% of SCC cases the EGFR, KRAS and ALK mutations are noted presumably from the mixture of cell types (adenocarcinoma + Squamous Cell) these patients after a Cisplatin based chemotherapy regimen show a 18% response rate to the small molecule targeted inhibitors such as Erlotinib, Afatinib. SCC is a well known entity that occurs secondary to dysplastic changes in smokers and other environmental toxins. These dysplastic cells have variable damage to the genetic structure early on. Further oxidative stresses to these dysplastic cell lines increases the genetic mutation burden and leads to cancer.

The following targets have shown success in SCC:

  1.        Monoclonal Antibody PD-1 (Nivolumab) and (Pembrolizumab or MK-3475 an Anti PD-1) an immune checkpoint blockade in unselected SCC cases lead to a 16-23% response rate and disease control rates of up to 50%, especially with the PD-L1 over-expressers. Smokers seem to benefit from the anti PD-1 and PD-L1 checkpoint blockades. Anti PD-L1 agents currently in Phase i/II trials with encouraging early results include MPDL3280A (atezolizumab) showing a 25% improvement over Docetaxol in a head to head comparison.
  2.        Anti CTLA-4 (Iplimumab) that restores downstream immune activation against the cancer has had limited success in SCC with Phase I/II trials in progress against advanced NSCLC SCC patients.

We have come a long way in securing newer targets to attack against Lung Cancer. The success will ultimately depend on the durability of the response in improving overall survival hopefully with improvement in the Quality of life as well. Combinations of molecular targeted therapy with Immune checkpoint blockade as well as Restoring Immune surveillance in limited disease lung cancer can be personalized to the patient in the future.

There are many other paths that have yet to be travelled...

Only the curious have, if they live, a tale worth telling at all - Alistair Reid

Tuesday, December 8, 2015


"There are more things in heaven and earth, (Horatio), than are dreamt of in your philosophy"

Cold or warm, tired or well rested, despised or honored, hated or loved, happy or sad, we all face life in its many varied forms. The trauma of existence is placated only by the moments of free thought, of fulfilled desire, of understanding. So what is in these many moments where life exists that makes us want more.

Turns out, if you have time to pay attention to little matters of time where true grit as true happiness lives, you might come away with that it is in seeing the joy in another’s face.

Nowhere is life more evident, more clear, more raw as in caring for another human in need. Physicians qualify in this realm more than in any other discipline.

Physicians live in a unique world of elation and despair. The wildly gyrating confines of this existence gives motive and cover to the mind of a physician. That one patient who finds cure from an interminable illness promises the healing for the many in despair. Each person is a life, each person a story, each person a face of society, brings with him or her a quality unique to humanity. No two individuals are alike. Therefore no two can be treated alike.

The former President Jimmy Carter just made news with a report from his recent cancer follow up MRI that showed complete radiological remission of the brain metastasis from the malignant melanoma.  His treatment included radiation therapy and Keytruda, an anti PD-1 immune therapy. There are several interesting and promising signs from this reveal. First, healing an individual and especially a former president at the age of 91 is worth noting. So age should not be a limit to proper treatment at any age. Notwithstanding experts like Zeke Emmanuel, MD who implied that after 75 years of age, people should not be treated and that they should be retired to the pastures. The obvious flaw stands out in stark relief now, doesn't it? Second, aging individuals have a lot of wisdom to offer and the young ones should take note of any pearls they drop in their communications. it is obvious that President Carter has a lot to say about his life and the world he has inhabited. Whatever that wisdom is. Wisdom is a philosophy on to itself. And you ask what is Philosophy? nothing more than the “love of wisdom” as Pythagoras called it, or the knowing the underlying fundamental nature of reality. One can tease at the fibers of this philosophy fabric and even in its threadbare form it reeks of some ancient understanding steeped deep into the veins of knowledge-keepers where blood flows.

Philosophy must be wise and therefore rational? Right? “ça dépend!” It depends on many things, but most of all on the questioning of all that is there. An individual’s philosophy would differ, based epistemologically on his or her beliefs, ideas, attitudes of the community and nurturing.

Our philosophy is nothing more than an improvement in our understanding of nature and ourselves. So should we then change the current thought paradigm that places age and cost ahead of fixing illness?

Consider this question; Should we advocate death as the primary focus in healthcare? Some will proffer the cost as a major hurdle for treating the elderly. They will claim that healthcare costs are currently 17% of the GDP in the United States. But they fail to recognize that costs are not due to the care administered, but as New York Times recently pointed out; a direct result of the business people involved in administrating the business of medicine.  So if that vital middling managers can be eliminated, the cost of care would come down drastically and become at once really affordable. More people would get treated and their insurance carriers would not be averse to paying for the care while still making oodles of money for their CEOs (Median total compensation in 2014 for the 117 CEOs for whom Modern Healthcare collected compensation data was $5.4 million, with a median increase of 9.6% over the prior year) and their shareholders.

Consider another question; Should we use a standardized lesson plan of “Choosing Wisely” as advocated by the American Board of Internal Medicine and co-opted by other entities like American College of Physicians as the correct model of patient care?  Experts say these programs are based on “Evidence based Medicine.” What is “Evidence?” I ask. Evidence changes as new information is received. So what is standard today becomes an “old thought: tomorrow. And further if the evidence is conjured by a set of tortured statistics, that furthers the illness within the science of medicine, how exactly does that further the agenda of good patient care? It is akin to building a perfect emptiness contained within straight lines in a chaotic world. Most of us would love to live within those bounds of comfort, happily suckling on sweet nectar without a care, but is that reality? Defining evidence is at best difficult! Yet if we claim “Evidence” as evidence enough to change belief of the majority, then all is pardoned and acceptable. And therein emerges the concept of “Evidentialism,” writ large "Evidentialism is a theory of justification according to which the justification of a conclusion depends solely on the evidence for it." The new subconscious is derived from consciousness at individual level and new belief becomes the new zeitgeist for that individual. And justification upon justification becomes the unwieldy latticework difficult to untangle for most except for those independent thinkers.

As the Big Data scientists gather their tools and computers, a cry from one of its own Hannes Leitgeib said, “ Overall and ultimately, mathematical methods are necessary for philosophical progress.” Ah yes, this progress, where we find the sinews of medicine wasting away today under the hard, weighty chains of pseudo-scientific tortured statistics. The general and special belief system slowly mutates to the turn of their statistical screw.

So, what is your philosophy as a physician in caring for your patient?

Maybe it is time for some Critical Thinking?
Maybe it is time for some thoughtful analysis?
Maybe it is time!