Ageism - scientifically speaking.

You are too old/too young to participate.  Sorry.

Unique Forms of Continuity in Space - Umberto Boccioni - MoMA  - 122813

In my last post a about Santa and Dollars, I wrote about many of the "isms" and the hope that they are fading away.  Friend UL wrote about an often overlooked type of discrimination - ageism.  It made me think upon a recent example of ageism I learned about that is part of science and clinical trials of medications.

As I've mentioned before, I work for a large pharmaceutical company in the pharmacovigilance (PV) department (Drug Safety).  We are the group that makes the list of all those nasty side effects that you hear listed in prescription drug commercials (e.g., dizziness, nausea, oily discharge, liver damage, etc.).  Most of these lists come from what is discovered as side effects during the three phases of clinical trials for the product.  When conducting these clinical trails, especially phase 3, you have to have very tight controls on subject selections so that  the product is being tested against the disease and eliminating outside variables, as much as possible.  To determine who gets the treatments (and depending on the target population of the medicine), you have to create a list of the Special Populations  of those that will be excluded from the study.  For most studies, the first two groups most often listed as special populations are pediatric and older patients.

Scientifically, it can make sense to exclude these two groups.  For too long, children were thought of as little adults when it came to medicine.  You just adjust the dose for the body weight.  This was a big mistake since the metabolism, brains, and organ systems of children are developing and are much different than adults.  In the past few decades, the FDA and other health regulatory agencies (MHRA, EMEA, SFDA, Health Canada, etc.) have increasingly emphasized the need for special clinical trials for children.

The older excluded group is a different issue.  Older humans tend to have multiple issues that can affect/draw questions to the clinical trials.  At 44, I am starting to age out of some studies.  That can be attributed to my needing two different asthma medications along with being on the verge of high blood pressure and cholesterol.  If I start taking meds for those, it would further complicate any clinical trials because of the potential issues of drug interactions and other pre-existing conditions becoming exacerbated.   As we age, we become more medically complex.  All of this can make medical testing very tough and is understandable for filtering out during clinical trials, but on the other hand...

The other hand is that by excluding these special populations, we don't learn what health issues the new product can introduce to the populations.  It may greatly help them, hurt them, or do nothing at all.  The danger can come though when the drug is approved and it gets out to the general population, which includes these special populations.  We often learn more about the side effects of drugs for these groups from reports of adverse events from marketed drugs than those in clinical trials, especially for special populations.  Sadly though, that meant a sick patient had to live (hopefully) through the adverse drug reaction.  Because we didn't test on these subjects, we may not know the issues caused by more-complex health profiles of children and our older communities.

When practicing PV, we don't only list the side effects, we build up a benefit/risk profile for the product.  We want to help the prescribing physicians, patients, and other healthcare providers by giving them the best and most current information on the drug.  This enables them to weigh the benefits and the risks of the product.  Many risks can be reduced or mitigated by taking special actions, so this knowledge is crucial for making the correct treatment plans.  To truly understand this, we must include special populations in the clinical trials and determine how the medicines work within them.  Sadly though, this isn't done, mostly due to the cost and time.

Currently it costs north of a billion dollars, not including production/manufacturing costs, to get a drug approved by regulatory authorities.  With the short trademark life on the product and that it takes 8+years to get approval, doing further clinical trials aren't deemed cost effective or time efficient.  For many products, warnings go out stating that data for special populations is incomplete or missing and that doctors should be very careful prescribing to them or should avoid prescribing them at all.

We (industry, regulatory authorities, insurance companies, advocacy groups, patients, etc.) need to determine a way to require further clinical trials that include special populations to ensure better data across all patient populations and yet makes it financially feasible for the drug companies to do so.  I think all sides need to be flexible and working toward a solution rather than trying to protect only their own interests.


Santa and dollars. What is real?

If you are under 12... you shouldn't even be reading this blog until you are 18

It happened on Easter Sunday when I was seven.  My family was staying at our Montana cabin out in the woods and my older brother and I were looking for all the goodies that the Easter Bunny had hidden for us.  At one point I had stopped looking and started playing with a toy when my mom said, "I bet the Easter Bunny would hide something behind that chair."  She pointed her finger and I ran off too check it out and found another small toy.  As soon as I picked it up I looked at my mom and the whole belief vaporized into myth.  

"Mom.  You are the Easter Bunny, aren't you?"  I asked with a sudden flush.

Her shoulders dropped and she said, "Yes.  I am."

It all hit me then and I kept asking and she, my brother, and my dad kept replying.

"Tooth fairy?"
With the biggest hesitation, "Santa too?"

She then told me not to tell any of my friends because I shouldn't ruin these things for them. The trip back home that day was quiet.  I had the last of my magical loot in the seat beside me and I felt suddenly much older.  The magic of belief and the belief in magic had evolved into knowing neither magic nor belief existed.  The fences going by and the telephone poles were more real than anything else that day.  

I don't judge the value to perpetuate the myth of Santa and his gift-bearing siblings.  It is up to parents to decide if they want to keep these magical myths going.  I wonder though why we create a *magical belief that is so rooted inside our culture to uphold.  If I say there is no Santa, people shush me and look to see if any kids are around.  It feels like I almost said "fuck and rape" by the responses and dirty looks I get.

Santa is based off of Saint Nicholas of Greece.  Over the years, he has morphed into his current version (and even that is changing with stupid debates over his skin color and his portrayal of obesity) that we perpetuate.  Along with him, the tooth fairy and the Easter Bunny continue to evolve and give better inflation-rated gifts over the years.

So again, why does our culture need these magical beliefs?  Are there other similar beliefs that we hold so true in our hearts, even as adults? 

I started thinking of things that once were not true, but now have become believed as true over the years.  I also started thinking of things that once were beliefs that are now gone or fading away.  Here are some of the first that came to mind.

  • Inferiority in intellect/moral fortitude of a gender, sexual orientation or race.  (Probably everything racist, sexist or homophobic is part of this)
  • Fear mongering of the enemies of a nation over the years - Communists, Soviets, Muslims, etc.
  • The sins of sex
  • Dick Clark never aged.

Along with all of these I came upon the biggest magical belief that almost every country holds.  It is so pervasive that our existence holds its value to be so important that wars, murder, and mayhem go crazy over it to hoard.  It is the dollar, yen, euro, pound.  It is money.

I have an old twenty dollar bill from the 1950's.  On the front it states:
This note is legal tender for all debts, public and private, and is redeemable in lawful money at the United  States Treasury, or at any Federal Reserve Bank.

If you look at one printed now it says.
This note is legal tender for all debts, public and private. 
As many of you know, American money was once based on the Gold Standard in which the paper money was representative of actual gold held in reserve as the backer of value.  At one point though, this was done away with.  That new twenty dollar note is not worth that much because the paper it is printed on is not made of expense materials.  The ink is pretty cheap as well.  It isn't a note that can be directly exchanged for gold stored as proof of value.  That twenty dollar bill is only worth twenty dollars because we have ingrained it into our minds that it is worth it.

If I went to the store today and bought twenty dollars worth of groceries tonight and still had forty left in my wallet and then the zombie apocalypse hit, which could I use to exchange for other goods or services, the left over money or the groceries?  The can of spam would be worth much more than the piece of paper with $20 on it because it truly would have value as a consumable.  In that moment, aside from fighting off zombies, everyone would have the same realization that I had at seven about Santa.  Money isn't real.  Fence posts and telephone poles are real.

I started to see this a few years ago during the recession.  My 401k dropped in value by 75%, as did my home.  One month I had x dollars invested, the next I had 1/4x.  I didn't see any of this stuff happen.  It just disappeared.  On the other hand, my home was still there.  Even though it was worth much less money than it was a year before, I didn't lose an actual 75% chunk of it.  It is still 1410 square feet, two stories high, with a detached garage.  It is the magic-belief-paper-money value of it that was lost.

It is things we truly consume that have value.  Food holds value.  Shelter is valuable.  Medicine is pretty good too.  What about jewelry?  That depends on whether its beauty is valuable or its components hold value for use and in other modes.  What about ideas?  Good ideas are valuable, such as the idea of better way to build a wall to keep zombies out.  That would be worth some spam.  Good music would be valuable as an escape and reprieve from existence, as well as books and other arts.  Friendship, family, and human bonds would be worth much too as our ancestors learned by living in communities.  Of course the value, and trade, of the world's oldest profession will never change.

In this season of giving, stop the craziness of thought that the price tag behind the gift makes it better.  I know it is trite to repeat the cliche of "It isn't the gift, it's the spirit of the gift that counts", but it is true.

I had a coworker look at me, mouth agape, when I told her I was getting my wife a massage and making her dinner for Christmas.  She then stated (semi-joking), "There had better be a Gucci something beside that dinner."  I just smiled and walked away knowing that for us, a relaxed and nurtured body massaged of stress and filled with amazing pot roast is worth more than something sold at Bloomingdales.

*I am not addressing issues of faith and religion with this post.