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After I was diagnosed with fibromyalgia in 1997, it was suggested to me that I might benefit from joining a fibromyalgia support group. My first and only experience with a support group was a jaw dropping experience; I realized immediately that this was not

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

the place for me, and that those who were present at this meeting worked very hard at validating each others perceived disabilities.

Oh, don’t get me wrong, the pain of fibromyalgia is real, very real indeed. I’ve had tears pouring down my cheeks, as I st

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

Examples of combination products may in

ruggled to make it from the bed to a scalding hot shower. But ten years later, I have long since recovered, and live a very active and physical life with minimal interference from this neurological quirk.

Researchers have recently discovered something that

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

hints at what I felt intuitionally at that fibromyalgia support group meeting so many years ago.

Dr. Jeffrey Mogil, of the University of McGill has concluded that mice have the ability to show empathy. In their study at the Pain Genetics Lab at McGill Uni

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

versity, they discovered that mice that were allowed to see other mice in pain, later tested as being more sensitive to pain than the mice that had not.

Now, this is a breakthrough for researchers studying empathy, simply because even though it has long be

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

Combination pro

n suspected to be felt by the higher primates, it had still remained unproven. These findings have other implications as well.

Let me ask you, if you are already in pain, do you want to become even more sensitive to pain? Of course not, right? But that’s e

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

xactly what the research is telling us; when you are around others who are in pain, there’s a very good chance that you too, will develop amplified pain signals.

In the numerous one on one session’s I’ve had with people who were suffering from chronic illn

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

esses such as fibromyalgia, teaching them leading edge strategies for effectively managing their discomfort, I’ve had the opportunity to ask all of them about their experiences with support groups.

Never, not even once, has someone told me that they had at

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

tended a support group meeting where they were told, “Okay, as bad as it may suck right now, the fact is, you are currently suffering from fibromyalgia. While for some of you the pain may be inevitable, you had better understand one thing…the suffering is o

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

ptional; we will not tolerate complaining and whining about how bad you have it. We will work with one another, sharing things that are making us feel better, knowing that we are all striving for the same goal…to feel better, but that won’t happen if all we

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

do is talk about every ache and pain, and how bad we feel.”

One of my clients even told me that the support group they had belonged to had one major purpose, to push for men and women with fibromyalgia to be able to more easily and quickly get disability b

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

Following aspects would a

enefits. Psychologically, this mind set spells doom and gloom, and a future of suffering.

Think about this for a moment, if my primary thrust is to be able to qualify for disability, then I have already accepted as my reality, that I will be incapacitated

dd to the challenges in developing combination products:

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

by fibromyalgia the rest of my life. I don’t know about you, but that is simply not a belief that I want to settle down with.

Fair or not, I have always been extremely reluctant to work with anyone as a client who was receiving disability benefits. This a

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

lmost always creates a very tricky situation, one that can be difficult at best to overcome. What you have, is someone who is in pain, and has a good portion of their bills paid each month by the disability payments. You’re saying to them, “I can help you g

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

et back to the point where you have to work again, and pay your bills with the money you earn after a 40 hour work week.” As you might have guessed, most people dig their heels in deep when it comes to giving up free money, even if it means they might be pa

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

n free.

My advice is always the same; find out for yourself. If you’ve been thinking about a support group, then by all means go, and perhaps you’ll be fortunate enough to find a different group than most. If so, I’d love to hear about how the meetings are

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

Professional from academic institutions, pharmaceutical industries, health care indust

orchestrated. If however, you find that you’ve stepped into a den of pathetic complaining people, with no sense of direction or outcomes for their future, then run or walk as fast as you can, and know that feeling better is almost certainly a possibility.

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

Therapist and Author Paul Watzlawick once said, “The person that commits suicide arrives at the conclusion that what he is seeking does not exist; the seeker concludes that what he has not yet looked in the right place.”

Know in your heart that the wisdom

.

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

of Watzlawick is your truth, things can get better, no matter what you are facing in life. Stay away from those who only complain and talk about how bad things are, and what they can’t do. Even if you currently struggle just to make it through each day, an

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

Companies that provide selfless information through particip

d are dealing with unthinkable tragedies in your life, seek out those who look to the future; find those that are there for you, but that who refuse to condone your acceptance of misery as a way of life.

© Copyright 2007, Vincent Harris-All Rights Reserved

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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