Day 100

Let Observation begin with the presumption that most people who will read this are pursuing success in one field or another.  This pursuit may be in a work environment or in a recreational pursuit, or even an academic field; but almost assuredly you are seeking success. And it may be surmised from this pursuit that you either equate the effort to accomplish or the actual success with your ongoing happiness. But how do you know when you are successful?

In the zero-sum world of near unadulterated capitalism there is typically only one winner for any given competition.  Let it be interjected here, in a tip of the hat, that there are new trends in business management; working models of sustainability look to change the goals of businesses from pure shareholder equity growth via limiting progress measured by profit line comparison to long term strength of relationships with customers, suppliers and the community in equal measures.  But most people who are reading this will have developed their sense of success on the old zero-sum, winner take all approach.

So let the Observation shift to a look at 5 people in the battle against cancer: The Patient, The Nurse, The Doctor, The Hospital, and The Pharmaceutical Company.  My personal experience with Insurance Companies leads me to believe that their role in the cancer puzzle is remarkably neutral, only when we realize we did not have enough coverage do we find ourselves calling for insurance company or health benefit reform.  This complaining comes because we often hold the extension of life more precious than the life that is lived to the fullest.  Once again a topic is touched upon that is worthy of its own separate discussion; so more on that later.

For this moment let’s look at our 5 people and see how they define success: The patient would appear to be the simplest but that view is almost always seen from any point of view but the patient’s.  Success is not just beating the disease, but beating it while remaining intact.  To keep one’s body whole along with maintaining vibrant healthy relationships with family, friends, and co-workers is no easy task on a day to day basis for those of us not fighting for our lives against an invisible foe.  To accomplish while fighting against millions of uncooperative over-replicating automatonic cells is virtually impossible. 

It is in attempts to compensate for this inadequacy the patient will seek either solitude, or to develop the acting skills of a Meryl Streep or Laurence Olivier.  For the cancer patient success is defined as actually beating the disease or presenting the façade of not letting the disease beat them?  If they do beat the disease, rarely are they left whole either having lost body parts, friends, family or all three.  If they manage to fool the world into believing that they are going to be okay with the ultimate sacrifice, the world showers them with pity and love until pass away, and the legacy of their fight is perhaps memorialized in obituary or on a headstone.

The Nurse is the most challenging person to try and define success.  Decision making is limited, so the consequences for patient outcome are minimized. But as the hands on part of care giving, the Nurse receives the most input from patients, family, Doctors and hospital.  Much of this is positive input even if demanding, but the few negative inputs coupled with the realities of caring for people who are in all likelihood going to die from their disease takes an immense personal toll.  Many oncology Nurses can only handle 3 years or so before the stresses make it impossible to continue giving the best care and they become jaded and in need of either counseling, medication or both.  The sure cure to this situation is of course to move onto another field, but some are so touched by the strength and courage of their patients that they commit their lives to this field. 

Success for the oncology Nurse may be as simple as being to go home each night and getting a good night sleep before getting up the next day, returning to work and greeting the new day with a smile.  Success can be defined as perseverance of a compassionate heart in light of all the tears and pressures to address all the administrative crap that comes with the job.

Success for the Hospital, a corporate person, is defined as keeping the doors open while seeking to gain the largest market share of patients.  To accomplish this goal it must balance a quantity of patients many of whom are un- or underinsured against maintain a quality that allows them to keep accreditation, recruit a working supply of adjunct staff and nurses, while keeping the Doctors as happy as possible.

Much of this is done on the financial backs of those patients who have adequate insurance coverage.  Adequate is a subjective term here, subjective to the Hospital’s perspective.  Over charging for procedures, services and supplies is moderated by Insurance company standards of ‘Reasonable and Customary’ charges.  Such modifications by Insurance companies still compensate typically in excess of 200% of actual costs, indicating that a 200% profit on all insured patients should offset the unrecovered costs of the un- or underinsured.  Consider the most expensive and expert building contractors only charge 20% for overhead and profit. 

The costs absorbed by caring for the un- or underinsured should be covered; and yet the pursuit of the co-pays, deductible and co-insurance of the insured is a tenacious job worthy of the meanest pit bull.  To all the pit bull owners of the world, I am sorry for the comparison, your dogs are worthy of much better company. It is these incidental fees that often cripple the financial health of the patient.  In Evan’s case, the main hospital billed over $475,000 to our insurance company, the insurance company paid almost $300,000 of these fees, and we were left to pay over $28,000 in other fees.  Had we not had insurance, the expenses would have been written off or upon legal pursuit, been wiped out in a bankruptcy proceeding.  All this after the Hospital had already received a king’s ransom.

If this were any other business, a poor outcome would have resulted in non-payment, price adjustment or refund, but Hospitals success is like that of a professional baseball player.  If they get it right 3 out of 10 times they are considered good, 4 out of 10 they are elite.

As complex as the success for a Hospital might be, success for the Pharmaceutical Company is a lot simpler proposition.  Make enough money by selling those items that no one else can produce while keeping the R&D moving forward and keeping regulators at a safe distance.  For the last 18 months of treatment at our local hospital Evan received an injectable medicine called Temsiorlimus it was listed at $5,000 on the hospital bill, was being administered ‘off label’, given once per week and required Outpatient Clinic Administration. 

Temsirolimus is an mTOR inhibitor. mTOR is the acronym for mammalian target of Rapamycin.  Some time after the completion of the Human Genome Project, a number of scientists looked at the effects of certain previously established medicines upon cellular functions.  Rapamycin was one such drug, and it interacted in a manner that restricted the amount of proteins any given cell might produce in the body.  Because proteins are the building blocks of cells, Rapamycin was considered a possible cancer fighter. 

Once a drug is discovered, a patent is filed with an expiration date of 14 years.  So from discovery to the end of the patent is the maximum period of profit, because after the patent has expired, then anyone can manufacture the drug at cost and sell for a modest profit.  The discovering agency has a window of opportunity to make enough money to offset discovery costs and make as large a profit as possible before generic drug makers enter the market and sell the same medicine at cost plus a reasonable profit.

Discovery costs are broken into two categories: Efficacy studies and Safety studies which are supposed to run side by side and be overseen by the FDA.  Rapamycin as an already approved drug with an expired patent would never be the researched into cancer treatment because the discovery costs could never be recovered before generic manufacturers undercut the price. 

So Wyeth purchased the drug and set about developing an insignificant change to the chemistry of the medicine so as to gain a new patent.  The drug Serolimus was developed without intent to take to market, but it establish a patent protection window.  In the midst of patent protection Wyeth reconfigured Serolimus to create Temsirolimus and sought to take the drug to market for a rare cancer that would not get the attention of the generic manufacturers.  Upon approval in that field Wyeth began the effort for widespread use of the drug in other oncologic fields by promoting study centers and paying grants to doctors to research the newest medicine with the longest patent protection.

US consumers bear the greatest brunt of cost recovery due to the high returns on health insurance for those that are covered.  As a result, the Temsirolimus that was sold at $5,000/dose before hospital delivery costs, is available through a Canadian pharmacy for $200/dose, and Rapamycin a drug that does the same thing but doesn’t require any hospital time $53/dose.  For my money, Pharmaceutical Company success is judged as being to milk the US American public for the most money for the longest time.

Enter the final person for observation today, the Doctor.  I respect the frontline clinical physician as one of the most underappreciated and least respected occupations in the world; however the greater the degree of specialization and sophistication the less enamored of them I become.  My personal experience has led me to see the best surgeons as the most arrogant which is to a certain degree necessary for the person who is willing to cut into a body to make it better.  And given my own hubris, I have found myself at odds with such arrogance.

But the Pharmaceutical Oncologist is a beast of another color.  They accumulated enough knowledge in such an odious field to be considered the best clinicians in the cancer arena; but as they wear the uniform of clinical physician they do so as they walk around in the masquerade guise.  Their real identity is that of the Experimental Scientist.  Except instead of cell lines, rats or mice, the subjects of their experiments are human beings.  And this is where the ethics gets fuzzy until you look at the money. 

As compromised as the Hippocratic Oath has become, at the core is the fundamental motto that we assume all physicians hold dear, “First, do no harm.” And as we all desire the best care when faced with unique or life threatening diagnosis we flock to teaching hospitals and seek out the ‘best’ doctors in the field.  When needing a cardiologist or cardiac surgeon, there is little to be discussed as the workings of the heart are well known and understood, it is the skill of the Doctor in interpreting the individual cases that sets them apart from their peers.

But what sets an Oncologist apart from their peers.  As much as we advance the knowledge of cancer as a field, we still know so little about the individual specifics, and more research is done on how we respond in generalities to various protocols of processes rather than to curing the individual.  The emphasis is on the disease process rather than the individual.  So the best Oncologists are not necessarily those who have had the greatest success, but the one’s who have been published the most in the most respected peer reviewed journals.

As Doctors are evaluated on how many patients cross the threshold of the hospital, the Oncologist who develops the highest profile by having the most/best articles published getting the notice of the referring physicians is critical to status.  The clinical physician disguise is maintained throughout the course of treatment, but once a patient enters Stage IV they are immediately evaluated for what locally available study is open to them.

Locally available means that a pharmaceutical company is willing to fund the research, the hospital still gets its cut from insurance, doctor gets to double dip as they are also paid out of the grant as well as regular fees and gets to do the research that may lead to publication, and the patient is given ‘hope’ while having been transformed from patient to guinea pig.

So unable to ask this question during treatment or upon revelation; Why was Evan denied Radiation Therapy?  I can now answer: He was denied because that would have led to less income and prestige for the doctor/scientist.  Triaged with a black tag upon entering one person’s Stage IV, he would be of no further value to the pharmaceutical oncologist if his tissues could not be used for experimental treatments.   

Today is 100 days since Evan suffocated to death because of the among other reasons, the hubris of doctors, the unadulterated profit motive of pharmaceutical companies, and a lack of unencumbered ethical oversight by a disinterested third party board at a hospital.  

When I began to pursue admission to medical school to be a better advocate for Evan, I was naïve but motivated.  Now that I have seen the system and recognized its need to be reformed, I find myself stuck in a place lacking motivation.