Advice Pool - Health and Fitness

Chelation therapy, the use of chelating agents such as Detoxamin EDTA to remove toxic heavy metals from the body, was once looked dow

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

n upon by a large segment of the medical community as not having been proven to be effective. This is because early clinical studies

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

Examples of combination products may in

of chelation therapy were flawed due to using too few subjects, unacceptable study design or scientific bias. But these problems were

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

largely overcome after the publication in the Journal of Advancement in Medicine in 1993 of a study by L.T. Chappell et all, who look

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

ed at the effects of chelation therapy on nearly 23,000 patients. Of them, more than 85% showed an objective benefit from chelation t

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

Combination pro

erapy. Since that time, the number of success stories has continued to increase.

Unfortunately, the problem of toxins such as heavy

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

metals accumulating in our bodies has also been increasing. We are repeatedly told by environmentalists that planet earth is getting

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

more and more poisoned from the build up of toxins including lead, mercury, aluminum, cadmium, arsenic and others. The adverse effect

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

on human health of these heavy and light metal poisons has become so great that a name has been assigned: Toxic Metal Syndrome. It ha

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

s been estimated that more than 90% of all the people living in the industrialized world have at least one of the health problems ass

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

ciated with living in a toxic environment.

Listed below are only a few of the behavioral, structural and functional abnormalities li

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

Following aspects would a

nked to three of the most problematic toxic heavy metals:

Mercury - Depression, hallucinations, obsessive-compulsive behavior, chron

dd to the challenges in developing combination products:

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

ic fatigue, suicidal and aggressive behavior, anxiety and attention deficit disorder.

Lead - Spinal cord alterations, kidney damage,

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

increased heart rate, suppression of the immune system, birth defects.

Copper - Skin problems such as eczema and rashes, headaches,

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

muscle pain, decreased red blood cell count, cirrhosis of the liver, hepatitis, convulsions and seizures.

Detoxamin EDTA works diffe

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

ently from traditional chelation therapies, in that it does not have to be administered as an intravenous drip in an outpatient envir

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

Professional from academic institutions, pharmaceutical industries, health care indust

onment by trained nurses or other medical personnel. Instead, Detoxamin EDTA is available in a suppository form that can be used in t

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

he privacy of one's own home. In severe cases, it is recommended that one suppository be taken every night for 90 days. For less seve

.

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

e cases, such as individuals who are interested in chelation therapy for prevention or anti-aging, Detoxamin should be taken every ot

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

Companies that provide selfless information through particip

her night for 180 days. In addition, supplementation with vitamins, minerals and trace minerals should also be taken on a daily basis

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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