Less than 20 years ago, Tupac was sharing his sentiments about our nation not being ready for the attenuation of race as a negative factor in the decision-making process for presidency. We “weren’t ready yet for a black President.” On MLK Day, we see a sliver of evidence that people are beginning to judge men and women based on the content of their character rather than on race, gender, and slowly every other aspect of physical appearance and facets other than character and merit alone.

Though, it is frustrating that change is fundamentally addicted to a tranquilizing drug of gradualism, we and life are changing. And, it’s incremental steps forward (with some accidental steps backward) which result in wonderful feats. It’s that combination of pushing ourselves beyond our limitations, then allowing our expanding tides of growth to recede as rest awaits, which allots us the gusto to move forward when the sun rises again. We all move at our own pace — but, we all move forward.

http://www.theamericanconservative.com/articles/the-myth-of-american-meritocracy/

http://www.cnn.com/video/?hpt=hp_c1#/video/politics/2013/01/21/bts-obama-inaugural-address-inaug2013.cnn

Is this a wise decision? Is this not? Is it the right one or wrong? In my opinion, it’s a values decision. It’s a decision that rests upon our belief that we are capable of making decisions ourselves and living with the consequences. Whether we change our previous approval mechanisms or keep them the same, will reflect the answer to that question. What do you think?

Given this analogy of medicine to customer service, what could we do to innovate here? I think the goal would be to have a cult of hackers, much like Facebook, who understand the system. Understanding the system at a technical level is a given. Features built on a lack of technical understanding are doomed.

Funny, it is. Deducing the molecular, cellular, and bodily aberrations. What is it that’s uniquely different in this person’s situation, which results in their description of a problem to be like such?

What are they talking about? Is it the X system, the X system? Key is understanding the systems of the body. The logical deduction is the core competency here. Given the complex nature of the body, is there a way to address the differential diagnosis and soft skill of diagnosis and aberration finding? Watson and others will try to look at Natural Language Processing and fancy searches to crowdsource the knowledge of journals and SOAP/H&P notes to discover common diagnosis. Soon, you will have a structured association pairing of differential dx and their results. I suppose this is the most exciting/crowdsourced model, which ideally would be best supported through the HIE move and HITECH Act. From this point, if data is successfully been anonymized, then one could parse through here to look at diagnosis from subjective data. This would give us an idea of what is right and wrong through crowdsourcing many differential dx.

Then, we could test for those most probable aberrations with molecular and cellular analysis?

There were some very interesting debates here. Namely, two of which I’d like to contribute –

1. Whether the old are wiser than the young...

It was said that maybe there should be a law that no president should be elected who is older than 65.

Point 1 :

Possibly the most distinguished creator ever said, ”One who cites authority adduces not by intellect but by memory.”  The danger, when someone backs up their arguments by “authority” (e.g., my 20 years of experience), the risk is not having a discussion with a team on the matter and overlooking key aspects of the problem. Countless studies (this book cited many of them throughout) show that experience can even bias decisions and lead to more deleterious results than ignorant decisions. Fascinating but apparently true.

Point 2:

The above statement about citing authority and experience versus logic isn’t to poo-poo experience.  The point is rather to share that experience isn’t everything.  This isn’t to say that it’s worthless though.  Our brains take in experiences day-in and day-out.  What we remember though, are concepts over time.

Speaking with my grandma the last time or so, she reminded me of this — saying, “you know Ryan, over all my years it isn’t really the details which are important, but the concepts.”  And, while I see this framework of thinking to be potentially biased, it’s also highly valuable and true.  The funny thing of the world is it seems to work very similarly.  We/humans have begun to define this similar organization as “fractals.”  Certainly fractals are in their early stages of research and understanding, but it seems plausible to think that a set of guiding principles, if applied to different specifics and scenarios, will yield positive results (hence the benefit of conceptual thinking).  This is a valuable lesson from a person with experience, giving a young person who may think about memorizing details, details, details — wherein it’s the concepts which actually matter.

That said, guiding principles–though reinforced experience after experience–need to be open to change.  After all, times/situations change and this is one of the best attributes of the youth (i.e., their values are not biased by previous situations, but can only live in the now because they have no recollection of the past and few thoughts of the future).  This is also the value of novel entrepreneurs, as they are able to create systems within an organization that never existed before (e.g., a Chief Happiness Officer).

In sum,

The old are no wiser than the youth and the youth no wiser than the old.  I believe wisdom is more dependent on the person you’re speaking with and which guiding principles / core values they let guide their actions.

2. Whether aging is beautiful and useful versus youthfulness...

It was said that maybe the beauty to aging is only beauty seen by those watching the aging, rationalizing the aging of friends and family.  Well, I propose that even some elders see beauty in aging, and that’s fantastic and there probably is beauty to it.

A lot of “transhumanists” and young people may argue there is no beauty to aging.  The likely truth is there is both beauty and detriment to aging.  Many older people like and enjoy the serenity of aging.  They don’t get fulfillment and enjoyment from the same actions they once received enjoyment from.  And, as psychologists know, everything psychological is biological.  This means that if you kept someone at age 20 biologically, for eternity, they would likely never appreciate the aspects of life they enjoy at their later age.  Part of the lessons and enjoyments elders experience are due to the gradual decrepitation of their bodies, in addition to decreases in certain hormonal secretions than were once secreted in youth.  These changes in biology aren’t necessarily bad or good, it just is what it is.  The truth of bad or good is we’re casting a judgement, but whether it’s bad or good is up to us…not the world.  Nature casts no judgement.

So, for those elders who defend the prospects of aging, I applaud them.  For they have chosen to see beauty in change.  They have chosen to see beauty in difference.  No one wants to leave elementary school into middle school, because they fear losing all their friends.  They are scared that life will no longer be as fulfilling, that they will lose these key relationships in their life.  Well, if these students continue the move into middle school (i.e., this change), they will either be miserable or will learn to appreciate and thrive in this new life, with new people.  Without a gained appreciation for the new, and in reverting back to “elementary school,”0 the lessons from those new relationships will never be realized and one will be doomed to the lessons of the same people and situations.  Herein, I propose the value of new situations, environments, and finding beauty in and embracing them.  This includes aging.  There is value there.  And, if we eventually decrease the rate of aging, we will have to find another way to discover such lessons.

What I Agree With

I agree in that a directional change is necessary away from today’s trend of increasing litigation and regulation and towards a system that harrolds the control of medical decisions being centered in the hands of patients and their service providers, and not outside parties.  After all, as the book mentions, it is the patient experiencing the trade-off and who should be making the decision involving risk versus reward, when attempting to access an experimental drug.

The Biased Method of Writing & *The Incomplete Information Represented*

1. Cleverly, this book (meant to incite political action and arouse emotional angst) isn’t shy to point fingers at trial lawyers and big government (two easy figures to point fingers at). (see page 58 and the entire book).  The book repeatedly asserts and refers to the FDA as a monopoly, which is probably true but no doubt brings about a negative connotation in the reader’s eyes.

2. It is also suggested that the FDA does not include the relative context of a particular disease’s severity in the approval of a therapy, when in fact this is not the case (cite FDA protocol).  - Pg 53.  ”This reaffirms that treating safety as an absolute condition, divorced from the context of a particular disease and a patient’s unique circumstances, is counterproductive.”

3. This book asserts off-label prescribing is a threat to the FDA, and says “in a worst-case scenario the FDA would require clinical trials and approvals for new uses of approved drugs.”  In the context, this statement implies off-label use of drugs is not based from rigorous scientific and randomized studies — which is the case. (see 1, 2, 3, 4, 5, 6) (page 50)

4. Cites patients are unable to access therapies which are in experimental phases of study, when in fact they can through expanded access and single patient IND.

5. Cites drug developers / pharmaceuticals cannot accelerate the approval process when a drug shows extraordinary promise in phase II studies (that is, the proposed “Free to Choose Track), when in fact Accelerated / fast-track Approval does provide for a solution in this scenario. Additionally, there have been cases (citation 1) where randomized studies have been halted because of ethical concerns.  The post-accelerated approval is also required (that is, the suggested Tradeoff Evaluation Database)

Use of a surrogate can save valuable time in the drug approval process.  For example, instead of having to wait to learn if a drug actually can extend the survival of cancer patients, the FDA might now approve a drug based on evidence that the drug shrinks tumors because tumor shrinkage is considered reasonably likely to predict a real clinical benefit.  In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer.  The drug company will still need to conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer. These studies are known as phase 4 confirmatory trials.

-source: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#accelerated

Unmentioned in the Book, but Something I’ve Heard

Real-time data, as has been mentioned to me, can hurt a drug’s prospect for approval.  For instance, patients accessing a drug through an expanded method (e.g., “Free to Choose Track” / Expanded Access) who report real-time data could show 10 patients died on this drug.  But, maybe all those drugs were stage IV, terminal patients.  This is obviously biased and should not be reason to stop a phase II clinical trial in stage III patients.  The point to remember is a Tradeoff Evaluation Database (real-time reporting) could only be utilized internally… even at this, it could be a deterrant for patients to join the trial later on, even if the 10 patients who died were all 1 month from dying anyway.

Mentions Compassionate Use and says FDA is not motivated for compassionate use, well it’s really physicians who aren’t incentivized rather than the FDA.

In the end,

Though this book briskly mentions such instances as mentioned above, the point that the FDA approval process needs a tweaking remains valid. Patients are not aware of their choices and the FDA should not have the authority to deny patients’ access to a therapy if the patient and the drug manufacturer (customer and supplier) agree to such a transaction, based on a free-market and independent premise.  Additionally, there are therapies which may be beneficial at a molecular level but may not be beneficial on a “surrogate endpoint” level (e.g., drug A does not result in tumor shrinkage, but does re-initiate TP53 activity<- a good thing).

Certainly many of the premises behind this book, like that consumer choice greatly enhances a drive for innovation and that doctors need to be able to experiment and innovate to treat their patients, are sound.  Additionally, the theoretical benefits beind the Free To Choose type of approval track could be extended to expanding the Expanded Access and single-patient IND tracks the FDA currently has available (e.g., the FDA could make this track available for any disease, condition or ailment rather than just serious ailments, allow drug developers and manufacturers to charge for this service, and for the patient to not be able to meet the inclusion requirements of the trial).  The “TED” idea proposed is similar to what already exists for Expanded Access programs.  Single-patient IND and Expanded Access programs pitch are to collect data on different, heterogenous populations that may provide information for alternate indications for that therapy (expediting the learning process of drugs).  These are just some of the ways the ideas in this book are already incorporated and have been incorporated in the FDA’s current protocol.  But, this is not to say the process cannot be improved.  We just have to look at what is in existence before we start throwing out new protocols.  In this case, we don’t need to reinvent the wheel, we just need an alignment. (car maintenance ref) =)

The clerk began to share –

If these companies making all this money spent some of it subsidizing gym memberships and giving people time to take refresher naps, then they (employees) would be happier, less frustrated, and would likely be more effective.

This man wasn’t wrong.

There’s much evidence that the combination of

1. Life coaching
2. Healthy habits (healthy food and exercise) and
3. Energy optimization (nap time)

all increase productivity drastically.  This feature set of employee “benefits,” which currently exists sparsely in most corporations and businesses, happens to be trending upward and growing drastically in a new wave of business operations and management.  The revolution and evolution of employee happiness is happening from the ground up in instances like this — where the grocery clerk told me he would leave in a second if he had a chance to work at Google or somewhere of the likes(!)–as well as from the top down in organizations like Zappos, where Tony Hsieh’s book is spawning a cult following and flood of people towards a Happiness Movement and influx of positive psychology into the workplace.

Did you know that being part of a group that meets regularly can make you just as happy as doubling your income would? *source: DH Website

What this means for the Old-School Company

So what does this mean for the older companies who give their two-week vacations and that’s the extent of their efforts to please employees?

What this means is that, as newer companies and old but innovative companies begin to adopt a bottom-line that includes the optimization of their employees happiness (one of the most important bottom-lines), the turnover of great employees will increase.  Why?  Because a job choice is a value proposition.  And, $75k per year is more than enough to live on if you couple that with a happy work environment that provides you with food, health benefits, a gym, nap time, and a sense of fulfillment and improvement.  Compare this to the $120k work-a-holic, punch in your hours job that’s the same all day, and the decision to stay or leave doesn’t look like a hard one to make.

In sum, as old companies fail to realize that employee benefits and happiness need to be key foci to retain top talent, reduce turnover and avoid the high costs of re-training, people who adapt to this new wave of company competition for talent will garner higher profits and eventually leave old companies in the dust.

How it will Happen

This shift in company culture and operations/management style will not happen over night.  It will take two gradual shifts in each person’s actions to bring it so.  The first is a shift in employees actions.  If employees don’t leave and actually cost these employers money, they will not thing to change (at least not the passive, non-forward thinking ones).

The other driver of this shift is the proactive business owners who make work fun and a happy place to come to every morning.  These are not the employers who throw benefits and money employees way, but rather those who sit down and talk with their employees — learning what makes each of those people happy.  This is the “HOW” in making employees happy — but, it all starts with the goal.

I don’t know about you, but I can’t want for this shift in the average culture of businesses.   Not just for me, but for my family, friends and everyone else.

But, in the end, this is why I succeed.  I succeed because I raise my head up high amidst failure — because winning is stepping up in failure and success.  It’s moving forward in tribulation and triumph.  It’s never stopping.  Pace yourself.  You’ll get there.  Just always remember that no failure should keep you out of the game.  And, acceptance of failure is okay.  Everyone fails, everyday.  There’s no shame in it.  Einstein failed. Edison failed.  And if anyone tells you to stop because you made a few mistakes and accepted them, then show them these people.  We all fail.  We grow up wanting to be actors, athletes, lawyers and doctors.  We change course when it ‘s not that important.  This is our natural vetting tool deciding our MITs (most important tasks).  My vetting tool told me to leave to make some money and focus on my life’s goal.  So this is what I’m doing.  Will I change course?  Maybe.  But I’m cool with that.  Flip-floppers are looked down on sometimes.  But, my fellow readers, don’t let the public dictate your feelings and actions — do what’s best for you.  Sometimes that means to change course; sometimes it means to move to Warp Speed.

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