IN SEARCH OF H1

Humans are constantly in search of meaning. “What is the meaning of this?” is a common refrain from an adult to a child while “what is the meaning of life,” is a common refrain in the mind of an adult. Somewhere in the what are you doing to what am I doing is our existence. We are constantly moved to making complex theorems while roaming in our mathematical world and are equally fixated with numbers when dealing with complex data. The long standing dilemma still remains much as we would like to shelter our eyes from it bright light, “Why do we exist?” On the other side the statisticians are constantly tweaking their assumptions to make bold predictions.

The world changes with every bit and byte of the unknown.

In 1965 the Medical world changed when Medicare “The Safety Net” for the elderly came into being. Soon thereafter physicians noting that accepting assignment and being paid directly from the Centers for Medicare and Medicaid (CMS) reduced the payment losses. It was the win-win zeitgeist of the era. Soon the aging populace, diagnostic workups and expensive therapies ballooned the projected expenditure for healthcare. With no skin in the game both the patient and the physician became secondary in the scheme of things. The patient wanted everything done (and lawyers made sure they held the doctors to that arbitrariness), the physician complied as the RBRVS rolled in, and both sides enjoyed the benefits. Soon electronics plowed into the mix and coding illness became the essence of care. Hospitals under the DRG realized coding ICD and CPT was a boon for their bottom-lines. The more the numbers of illness coded under each admission the better the payment. Specialty coding industries took seed and blossomed overnight. Experts pouring over the charts, crafting mechanisms to increase reimbursement per length of stay. In fact the lower the length of stay and the more coded maladies the better the scheme worked for the hospitals as well to garner a higher payment.

Realizing the increased outflow of the taxpayer money, the government set out to code the very patient-physician encounter adding “time” for each encounter and “eye-to-eye” contact as a means for payment mechanism. Failing this mechanism the concept of Electronic Medical Records came into being to capture the encounter in “meaningful” ways. The government initially paid 40 cents on every $1 spent by the physician for “going electronic.” This little venture cost the taxpayers close to $60 Billion and untold billions to the physicians and hospitals. Net result was that a few companies like Epic and Cerner with close ties to the government capital got wealthy overnight while silos of information grew without any interoperability between the many available systems. The physicians were now governed by the coding they did, the patient progress note now blossomed into several pages from the original intent of the SOAP as they copied and pasted with little meaning and by the amount of reimbursement that they might receive.

Meanwhile the patients continued to suffer as their physicians were forced into clerical work rather than clinical work. Disappointment and depression set in, in the medical community and physician suicides increased exponentially. The “abuse” of physicians through regulatory fiat dampened the core spirit of the physicians as larger and larger numbers left the physician workforce and a 125,000 physician deficit currently looms by the year 2025. Not to worry though there is a new body of online certified NPs and PAs to handle the excess load.

On the flip side of the healthcare clinical sector was the diagnostic and therapeutic industry under the influence of large publicly traded companies. The former built clinic centers near large densely populated areas to service the diagnostic needs and the latter produced an immense number of studies to prove their minimal incremental new pill was “significantly” better than the last one.

The null Hypothesis (H0 ) was under attack by the armies of statisticians hired by the diagnostic and pharmaceutical industries. H0 seemed not to have any backbone anymore. Any and most every study based on a few “Ns” seemed to defy H0. Nothing, it seemed was better than the new shiny box of pills.

Definition of Null Hypothesis: A type of hypothesis used in statistics that proposes that no statistical significance exists in a set of given observations. The null hypothesis attempts to show that no variation exists between variables, or that a single variable is no different than zero.

Suddenly all the attempted studies became insanely positive. Everything tested against the past, current therapy or a sugar pill was better. The pharmaceutical industry pressed new measurement buttons. The previously targeted Partial Response that advocated a 50% reduction in size of a malignancy as a consequence of therapeutic success, the experts in the industry now were comfortable with a 30% threshold. And the same experts who were content with Overall Survival that determined benefit of treatment X over treatment Y now were happy with the poor man substitute of Performance Free Survival (PFS). The measuring spoon size had shrunk. 

Everyone with a little bit of statistical knowledge jumped into the game. Another industry blossomed overnight. medical experts now abrogated their responsibility about discerning treatment benefits on patient using artificial assumptions to make things right in their “technical papers.” Many a professor’s tenure was made and many experts earned positions in prestigious universities all trying to outdo each other in the search of something called “significance;” The game of finding H1.

The statistical beast H1 had been unmoored, ripping its tightly bound chains and was roaming free in the wild. It tore through the countryside. It ravaged the poor vulnerable populace in its greed. The study of Epidemiology was bastardized and the p-value brought forth significance to everything that had none and meaning, where none existed. Logic it seemed had failed its own set of rules.

The world was spinning at a faster speed getting closer and closer to the Seneca Cliff, as Yeats’ words have come alive with force:

Turning and turning in the widening gyre   

The falcon cannot hear the falconer;

Things fall apart; the centre cannot hold;

Mere anarchy is loosed upon the world,

The blood-dimmed tide is loosed, and everywhere   

The ceremony of innocence is drowned;

The best lack all conviction, while the worst   

Are full of passionate intensity.