Advice Pool - Health and Fitness

I was in an accident in 2001 after which I started having intolerable pain. After seeing several different Doctors, undergoing Physical Therapy, and taking pain killers that left me unable to perform physical

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

ly and mentally, I was eventually diagnosed with RSD, Reflex Sympathetic Dystrophy. My fingers started locking up (with burning pain) when I used the keyboard continuously and got stuck around my coffee cup o

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

Examples of combination products may in

r anything else for that matter. I cannot use my arm to do anything repetitive or even extend it for any period of time. Sometimes my palm is sweaty and hot, another time it is really very cold.

My nails bre

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

k easily, I am unable to sleep at nights because painful cramps wake me up and they refuse to go away. RSD pain is debilitating as it limits my ability to be productive and to produce quality material because

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

of my loss of ability to focus with such severe pain. There were times when I was unable to cope as a Mother and Wife and I was difficult to live with. I am currently on medication that helps me to cope wit

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

Combination pro

h this debilitating RSD and enable me to function.

Sympathetic Nerve Blocks

I have to talk about my worst nightmare. First of all, when I went to my Primary Care Physician to let him know that I was in ago

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

izing pain, he looked at me like- I don’t see anything wrong with her- I sensed that he didn’t believe me and was reluctant to give me a leave of absence from work. All said and done, he sent me to all kinds

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

of specialists at my insistence, none of which could provide diagnostic test results to show that my pain had a source. One Specialist told me I had Carpal Tunnel Syndrome, dismissed me with instructions for

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

a few weeks of therapy and then told me to return to work. I did as I was instructed. The Physical Therapy only made the pain worse. I went back to work and found myself unable to focus, unable to recall si

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

ple information. I was trying to work even though I was in severe pain.Mental anxiety took over as I could not understand why I was not performing like I should. I set high standards for myself and was never

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

satisfied with mediocrity. I ended up seeing a Psychiatrist when my Sister told me that I was not coping, my personal life was suffering as well.

Eventually, I was referred to Dr Anthony Kirkpatrick a RSD sp

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

Following aspects would a

ecialist. He confirmed that I have RSD, Reflex Sympathetic Dystrophy….UH?…never heard of that before!!!

Dr Kirkpatrick recommended a series of nerve blocks. This can be done with or without being anaesthetiz

dd to the challenges in developing combination products:

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

d. Of course, I chose to get my nerve block under anaesthetic.There is no way I would lie still on that table if I saw that really big needle coming towards my neck.

These nerve blocks have helped me somewha

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

t. I find that for me, the pain becomes tolerable for a few weeks after the blocks, then it’s all downhill again.The blocks subdue the nagging pain, but the fingers still lock up, I still get severe cramps th

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

at wake me at nights and the pain worsens when I use my arm to do just about anything.

My Husband who has been there with me for the majority of my nerve blocks, told me that I rant and rave and disclose all

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

my secrets when I am recovering. While the anaesthetic is wearing off, I feel like I am riding on a wild roller coaster and I can’t seem to find my way out, it also seems that all kinds of information is comi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng at me. It’s scary and maybe this explains my wild behavior. I am scared to death of roller coasters.

There is a horrible side effect from having nerve blocks. My Right eyelid droops and makes me look Hide

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

ous. Thankfully this is temporary, or no more blocks for me. I keep out of sight after my nerve blocks.

Dr Kirkpatrick has recommended Sympathectomy, where the nerve is permanently severed. I have rejected t

.

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

is procedure as I fear that I would have a permanent drooping eyelid (possible side effect, not happened in many cases, but I won’t chance it). Sympathectomy would have the same effects as the nerve block. I

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

Companies that provide selfless information through particip

would be rid of the nagging pain but could still possibly have the cramps and the severe pain that comes with using my arm. But I will go for the Sympathetic Nerve Blocks just for whatever relief it offers me

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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