Your Space - Health and Fitness

Depression, the Next Step

In my last article we talked about being depressed, clinical versus situational depression and some of the obstacles encountered when

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

you are depressed.

I have found with my struggles with depression that it is a seriously convoluted tangle of paths as you try to work your way through. Before

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

Examples of combination products may in

my breakdown, I handled my depression very casually. I was used to it and dealt with it.

This was not always easy, as I worked all my life and had to control m

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

episodes so that no one noticed. After a bit of scouting around I discovered a great doctor who didn’t really think depression was debilitating. She gave me P

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

ozac and that held me for years. Each person has to find a medication and level that will work for them. Prozac may not work for you, as many other psychotropi

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

Combination pro

c drugs do not work for me.

Then came my years with an abusive husband, homelessness, loss of all I owned and a long fall into blackness. I didn’t emerge on th

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

other side. Rather, I climbed, slip, fell back, went forward and tried again. Ten years ago I was a scurrying little creature, afraid of everything and everyo

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

e.

Then of course I was in need of much different intervention. Luckily I am under the care of a wonderful Nurse Practitioner who is loving and concerned. You

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

can find all different views by doctors about depression. Some say, “Pull up your bootstraps, and get on with it.” Well, I had pulled mine up around my neck an

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

d still had to struggle. There is no average, no set parameters. Depression and mental illness are very person-precise disorders.

If you are in a position to

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

eed help, be very careful. Remember, no one knows you better than you. On the other hand, we can be misinformed and naive about our illness. It takes a balanc

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

Following aspects would a

with a doctor who listens to you and considers your opinions as well. It is a partnership in many ways. I find I have a very close relationship with my N.P.

dd to the challenges in developing combination products:

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

eep an open mind, and check to see that they are also flexible.

In my opinion, finding a medication - or learning to control emotions without meds - is a delica

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

te dance on a high wire. Remember that most drugs take time to work themselves into your system. It won’t bring relief right on the spot, and may mean several

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

hanges of medication until you find one that works the best. Be patient and willing to work with your doctor.

Personally, I have not found that I can go withou

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

medication. It was a very difficult decision for me, as my husband was a drug addict and I had a horror of drugs. But, for my well-being I tried many - eventu

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

Professional from academic institutions, pharmaceutical industries, health care indust

lly ending up back with Prozac, which seems to a good route for me.

One thing I am very decisive about is the “stigma” of depression and mental illness. When y

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

ou have a broken leg with a nifty cast, everybody signs it and it’s good for a stretch of sympathy. But when you have a “broken” mind - no one can see it, and s

.

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

they assume whatever comes to their mind. You have a right to be depressed and mentally ill. It is nothing you can change with the brush of a magic wand. The

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

Companies that provide selfless information through particip

best you can do is be realistic about your situation and help yourself as much as possible.

In my next article we will talk about living sane in an insane world

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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Your Space - Living With Depression - Part Two

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