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Verbal abuse, as I constantly remind the women I work with, says far more about the abuser than it ever says about you. That’s because although verbal abuse is

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

always levelled at you, it is never actually about you. What it is about is the abuser’s need to shake off his feelings of inadequacy, for a while at least.

Th

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

Examples of combination products may in

trouble is even when you know this with your head, it is hard to feel it in your heart, hard not to be swayed by the power of these negative feelings.

It seems

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

to be because feelings are invisible and intangible that they have so much power over us. We cannot defend ourselves physically from them, and so their destruc

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

ive charge gets in under our radar.

On the other hand, you could argue that as negative feelings are invisible and intangible their power cannot be proved. In

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

Combination pro

fact, the sole proof of their existence lies in our response to them; which is, of course, the only thing that we have the power to change. Because we have the

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

ower to choose our reaction.

I said as much on a teleclass recently. In reply to one woman, M, saying how much she struggled with the constant flak from her hu

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

sband, I observed that the words he chose had everything to do with him and almost nothing to do with her; from The Abusive Man’s Handbook 101, an abuser will ch

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

ose whichever playground level insult he thinks will hurt most. He chooses his words not with laser accuracy - although it may feel that way - but with the inte

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

ntion of scoring maximum damage.

M. struggled and failed to get her heart around this.

The point was too important to pass over. Since the problem lay with th

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

intangibility of feelings, I tried creating a physical image for all that M.’s husband was dumping at her door. It was, I said, as if her husband had dumped a

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

Following aspects would a

uge, heavy rucksack at her feet and said: “You pick it up” and she had, rather than saying: “It’s your rucksack, you deal with it.”

That worked slightly better.

dd to the challenges in developing combination products:

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

M. began to see the transaction in a different light, although the rucksack image did not really resonate with her. “Ok M.”, I said, “supposing your husband i

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

dumping something at your feet, what would it be?” She didn’t even hesitate. “A mountain of dirty washing”, she replied, with disgust.

Now M. loathes dirty w

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

ashing with a vengeance. She could see it clearly in front of her. She could smell it. She wanted no contact with it. The image repulsed her. Then and there

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

he vowed that she would not allow her husband, or various other people in her life, to dump their dirty washing on her ever again.

The image had given her the t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ools she needed to protect herself from something she saw as both disgusting and nothing to do with her.

Maybe a mountain of dirty washing doesn’t evoke quite s

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

ch a strong reaction in you, or maybe it does. If it doesn’t, what image physically outrages you enough so that you will refuse to have anything to do with it?

.

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

What thoroughly offends your eyes, your nose and your sensibilities? What do you find so physically disgusting that you have no problem believing: “That’s his,

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

Companies that provide selfless information through particip

he can deal with it”?

Because however disgusting that image is, it’s less disgusting than the verbal dump you’ve been attempting to shift.

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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