Advice Pool - Relationships

The internet and newspapers in the last couple days have the love triangle of astronauts Lisa Nowak and William Oefelein and engineer Colleen Shipman front and center. The implication: We can't believe such a th

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ing could happen. And, how in the world did it happen?

One of our cultural icons has been tipped and ripped.

But it does make sense why such a tragedy can happen (and love triangles are tragedies).

We can lea

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

rn. If we choose we can empathize with all the victims in this triangle. And, we can twist our thinking a tad so we might see ourselves for who we really are - the good, the bad and a lot of in-between.

The art

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

icle this morning read: "No one at the space agency saw any sign that Nowak was troubled..." Well, folks, everyone is troubled. I assume what they meant to say was "troubled THAT MUCH." Her behavior crossed a li

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ne and that was troubling not only for her, the other two in the triangle, but for NASA and those of us who believe this national icon serves as a model.

Let's take a closer look at Lisa, or more accurately who

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

m she represents.

Lisa is a model of power: the power of intelligence, the power of "can-do," the power of physical toughness, the power of perfectionism, the power of narrow focus and determination to reach go

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

als.

Here are some observations on this love triangle and the pursuit of this form of power.

1. Ever heard: "for every action there's an equal and opposite reaction?" That's true for our inner life. One pursue

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

mightily success and perfectionism and there's an inner part that doubts one's success and fears failure. Of course the part that fears is relegated to the background, far out of awareness, if possible. This in

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ner turmoil simmers.

2. Those who hold this iconic position in our culture (clergy, astronauts, therapists, CEOs etc.) don't want others to know of this turmoil. They hide. This exacerbates the tension.

3. Som

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e internal line is crossed and the tension erupts into some sort of acting out, perhaps dramatic or bizarre behavior.

Why should be we surprised?

4. Was Lisa suffering from an "I Can't Say No" affair? (Break F

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ree From the Affair) Did she tend to be a perfectionist, driven person? Did she start becoming obsessive about this triangle? Materials found in her possession indicated she had an elaborate scheme she was to pl

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ay out. As I indicate in my e-book, the behavior of "I Can't Say No" becomes increasingly destructive.

5. Another interesting comment in the article: "We were just talking about the fact that the old astronauts

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

from years ago were a wild bunch of people. They played around, some of them. They used to drink and go out a lot. Now — family people, churchgoing, very, very devoted. "

So...they were the "I Don't Want to Sa

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

y NO" kind of affair?! Interesting, isn't it, how "harmless" those kind are. Oh well, boys will be boys, you know! (And, come to think of it, they were all boys, weren't they?)

Love triangles still abound. They

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

merely arise out of a different set of circumstances and different cast of characters.

6. Psychological tests didn't uncover her "trouble." I'm not a testing expert, but I do know that tests do miss items. And,

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

I also know that there are those who can "con" tests, intentionally or unintentionally.

A characteristic of a "I Can't Say No" affair is denial. Truth is distorted, twisted and ignored. Or a world can be ratio

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

nalized and created that fits the perception that person desires. And, he/she truly believes it and leaves room for nothing else. Could this be Lisa?

A person in the "I need to prove my desirability" affair is

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

sometimes attempting to reconcile a history or incident of abuse. The capacity to dissociate from that event may be so powerful that the event itself in never remembered. It's as if it happened to a "different p

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

erson." Was there a "different person" Lisa?

We don't know of course. And, it is dangerous to analyze too much.

Let's learn from this event. We humans are extremely complicated. Infidelity and extramarital aff

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

airs are extremely complicated and emerge out a myriad of different scenarios.

Once we see the smaller pictures our perspective changes and we embrace more fully our complex selves and our complex relationships

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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