Advice Pool - Relationships

A bright, funny, professional woman I know struggled with a personal dilemma she could hardly bear to name. She was paralysed by shame. There were new directi

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

ons that she wanted to pursue in her professional life, but she felt she could not because it would have meant owning the skeleton in her cupboard. That skelet

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

Examples of combination products may in

on was a bad relationship.

Hers wasn’t a monumentally awful relationship, her physically safety was not at risk, nor was she subjected to public humiliation, b

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

t still it was bad enough to erode her sense of self. She had her reasons for not leaving for a while yet.

Now, while I would like to see every woman leave an

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

abusive relationship yesterday, I will never judge them. It’s not for anyone outside the relationship to judge. Still, I do care passionately about their lif

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

Combination pro

, their safety and their health.

This woman was ashamed to admit publicly that the relationship was bad because she was still in it.

Now this brings up all so

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

rts of paradoxes in our society. We’re very good at telling other people to ‘put up or shut up’, yet we tend to voice at least some of our complaints relentles

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

sly. Just a few weeks ago the world was exposed to the edifying spectacle of the England football team weeping shamelessly like 6 year olds when they dropped o

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

t of the World Cup, after a lacklustre performance …

It was - for me at least, crabby person that I am - an extraordinary example of the self-indulgence that

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

characterizes society… Far from being ashamed to show the world their weepy side, our gallant English footballers expected to meet with understanding and sympa

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

hy. Theirs was a burden for the nation to shoulder with them.

The woman I was speaking to felt obliged to shoulder her burden alone. She had learned to live

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

Following aspects would a

around the difficult situation in her personal life. At this point in her life it seems to her the least bad option. The problem is that it leaves a hollowness

dd to the challenges in developing combination products:

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

at the heart of her life. It leaves her, like the Bee Gees, with a ‘hole in her soul’; a hole that will not be filled until she is prepared to reject the sham

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

and own the failure of the relationship.

I believe there is a place for shame; it relates to wrongdoing, the things that we do that harm another person or soc

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

iety.

I do not believe that shame ever attaches to someone who lives with an abusive partner. What need can you possibly have to punish yourself when your par

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

ner is already doing it so effectively for you?

We all make the best decisions we can at the time, for the best reasons we have at the time. Whatever decision

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

Professional from academic institutions, pharmaceutical industries, health care indust

we make requires tremendous courage. There are no easy options in an abusive relationship. The question is: how can you best protect yourself from further p

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

sychological damage?

There is no place for shame in abuse recovery. Whenever you feel shame know that that is the abuser’s burden you are shouldering and embr

.

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

ce the feelings that lie beneath the stranglehold of shame. What you fight will persist, what you embrace will pass.

There may be immense sadness to being whe

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

Companies that provide selfless information through particip

re you are – that’s perfectly normal. Without the anchor of shame to keep it in place, it will pass must faster than you probably think.

(C) 2006 Annie Kaszin

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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Advice Pool - On Shame

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