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Having a child born with an abnormality is every parent’s worse fear – but what if you knew that problems such as autism, ADD, ADHD and other disorders were actually caused by a breakdown in a biochemical process and coul

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

d be reversed.

Some Background Information

Several years ago health researchers led by Dr Paula Bickle, made a breakthrough when they found that youngsters with autism all had immune problems, high levels of toxi

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

Examples of combination products may in

ity and alcohol in their bodies and were lacking in most of the amino acids – especially taurine; they also lacked a number of important vitamins (particularly vitamin B6, B12 and folic acid) and many minerals – particula

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

rly magnesium, copper and zinc. These nutrients are essential for the necessary biological reactions (which convert methionine to taurine) which eliminate toxins and, very importantly break down sugar.

It is this sensiti

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

ity to sugar (along with a number of other toxins) and toxic build up that leads to hyperactivity and behavioral problems including madness. Another typical sign is the presence of dark circles under the eyes – indicating

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

Combination pro

an allergic reaction.

Remarkably the researchers were able to reverse 14 of the 16 cases of autism through changes to their diet – which involved increasing their protein, fresh fruit and vegetable intake, eliminating su

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

gar and through supplementation with essential nutrients.

This same treatment process can be applied to ADHD and ADD – a milder form of the same problem. Here's a summary of some natural and nutritonal treatments tha can

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

be applied to ADD, ADHD and Autism.

Diet

Total elimination of sugar – this is for the whole family and not the child – you need to set an example; this includes all forms of refined sugar and processed

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

or simple carbohydrates.

Eliminate or significantly reduce dairy and grain – this is a source of allergies that the child will be very sensitive to – use soy as an alternate source of food.

Increase th

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

intake of protein to replace the missing amino acids.

Nutritional Supplements

Supplements can help by providing the necessary nutrients to make the biochemical reactions start to work again; they are

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

also needed to repair the damage caused by this toxic build up and to help children absorb nutrients.

Supplements include:

Plant derived colloidal minerals – these are over 98% absorbable and provide all of t

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

Following aspects would a

he minerals required for normal functioning.

Multi-vitamin / Amino acid formula in liquid or tablet form – vitamins and protein are required for correct metabolism, to replace the amino acid deficiency and to re

dd to the challenges in developing combination products:

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

uild the body.

Digestive enzymes to assist the body in digesting protein; the damage caused by sugar and other toxins will lead to very poor absorption of food.

Antioxidants are required to reverse the

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

affects of toxic damage caused to the body by the poor metabolism of sugar.

A chromium/vanadium supplement will assist in helping to maintain healthy blood sugar levels.

Drugging Our Youth

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

here are many other diseases and health challenges that affect children but we focused on these particular issues because they have such devastating affects on family and school life. These diseases can be treated or at l

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

ast controlled and improved and it doesn’t involve getting our children addicted to DRUGS.

Drugs such as Ritalin and Prozac only subdue the child while the problem goes unchecked. They result in drug dependency and signi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ficant side effects such as a worsening of the condition when the child is off the drug, drooling, drowsiness and explosive and violent emotions. There have also been no long term studies into the health risks associated

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

ith putting young children onto a dangerous drug.

Summary

Childhood diseases such as autism, ADD and ADHD result from a biochemical malfunction that results in a toxic build up in the child and their in

.

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

ability to metabolize sugar.

Diet and lifestyle changes require the total elimination of sugar and increase in protein and fresh fruit and vegetables.

Natural treatments involve supplementing with plan

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

Companies that provide selfless information through particip

derived colloidal minerals, a multivitamin/amino acid, antioxidants and digestive enzymes. These will repair the damage, get the body functioning properly and ensure that the child is receiving good nutrition.

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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