E-Articles - Health and Fitness

“We are guilty of many errors and faults, but our worst crime is abandoning the children, neglecting the foundation of life. Many of the things we need can wait

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 child cannot. Right now is the time his bones are being formed, his blood is being made and his senses are being developed. To him we cannot answer ‘Tomor

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

Examples of combination products may in

ow’. His name is ‘Today’.” Gabriela Mistral, 1945 Nobel Prize Winner.

In part one we recognized that as much as we have advanced in life as humans, we may ha

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

e contributed to potentially non reversible effects and damage to our selves as well as generations that have yet to follow. Here are some distressing factual

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

umbers and statements (acquired from the chemical legacy by Catherine N. Dorey):

The USA continues to have one of the highest infant mortality rates and the hi

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

Combination pro

hest rates of preterm and low birth-weight babies in the industrialized world (Altshuler et al., 2003a). The risks of developing the disorders which result in

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

infant death are all increased by exposure to chemicals.

The incidence of asthma, allergies and autoimmune diseases are increasing world wide, simply stop and

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

hink of how many people including yourself that you know of who suffer some type of allergy.

While there is no doubt that genetic predisposition is an importan

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

factor for development of immune disease, environmental factors play an important role in their development as well. Studies show that certain chemicals cause

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

changes in the immune system which affects the body’s ability to fight infections and cancer, to inducing allergy and autoimmune diseases.

Cancer is the third

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

ost common cause of death among children between 1–19 years (Anderson, 2001). It is estimated that 1 in 3 people will develop cancer during their lifetime. A

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

Following aspects would a

lmost all of us know someone or of someone whose life has been affected by cancer.

There is an epidemic of developmental, learning and behavioral disabilities

dd to the challenges in developing combination products:

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

n children (Shettler et al.,2000). The number of children being treated for attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD

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

has increased dramatically in the last ten years (Houlihan et al., 2003; Shettler et al.,2000). The reported incidence of autism is also increasing (Houlihan e

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

al., 2003). The causes are unknown but chemical exposures are considered to be a potential contributor (Wood ward, 2001).

Reproductive disorders, particularl

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

in the male continue to be on the rise. Things like low sperm counts, testicular dysfunction and testicular cancer have all been linked to chemical exposure.

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

Professional from academic institutions, pharmaceutical industries, health care indust

There have been hundreds upon hundreds of researches, articles, papers and news flashes urging people to understand why they or a loved one suffers from the ab

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

ve problems including many that I have not mentioned.

People seem to almost have a flat affect or are indifferent about such things. So I exposed my self or a

.

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

loved one to some chemicals…. there is not much I could do about it really. It continues to baffle me the reaction or lack there of I get whenever I explain t

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

Companies that provide selfless information through particip

people what it is they are truly buying and bringing into their homes from the grocery store.

Is it brand loyalty? Or is it the fear and uncertainty of change

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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E-Articles - Wake Up & Smell The Poison (Part 2)

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