Advice Pool - Health and Fitness

Why are Holistic medicines not approved by the Food and Drug Administration (FDA). Basically, we need to understand what the difficulties are of getting non conventional therapies of any sort approved by the FDA in the United States. Below i have given some expla

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

ntions why i believe this is the case.

The entire medical establishment alongside government agencies believe that only pharmaceutical drugs can cure a disease. Any form of alternative cure or therapy is as a result treated with disdain. Therefore, it is difficult

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

Examples of combination products may in

for Holistic medical practitioners to overcome these prejudicial hurdles in order to prove their effectiveness as a healing method.

Drug companies, which fund many of the studies for new drugs, have little or no interest in pursuing alternative treatments and cur

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

es. Since they are generally are inexpensive and cannot be PATENTED. Drug companies are in the business of making money with a drug that can be patented. You can not patent anything that exists in nature. You cannot for instance patent carrot or wheatgrass juice. T

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

here is no money to be made from spending millions of dollars on research to show that vitamin C helps to fight cancer, since anyone can buy the substance at the local drugstore.

The main criticism that the medical establishment has of holistic medical treatments

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

Combination pro

is a lack of traditional scientific testing and documentation. One reason for the absence of mainstream research on alternative treatments is that the funding institutions that provide the money for cancer research for instance do not support research into alternat

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

ive cancer therapies.

This situation creates a double bind for Holistic medical therapies: they are criticized for not having adequate research to document their effectiveness, yet funding is not made available for such studies. The conventional medicine experim

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

ental approach calls for checking one substance at a time, and this approach leads to a search for a "magic bullet" that would be the cure for a particular disease. However, the very nature of this traditional research methodology ignores the multidimensional natur

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

e of the disease. What is needed is new ways to evaluate the effectiveness of Holistic medicines. Diseases such as cancer and high blood pressure are multidimensional by nature. It is nearly impossible to study the effects of diet, therapeutic agents, and other i

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

nfluences in the conventional research framework. Investigating several variables calls for dozens of experiments and would require impossible amounts of research funding.

Another reason why there is lack of research into Holistic medical therapies for example is

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

that many of those therapies are offered as part of an integrated program. For example, the National Cancer Institute's laetrile (Vitamin B-17) study produced negative results. However, proponents of laetrile point out that the NCI study ignored diet, nutritional s

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

Following aspects would a

upplements, water and other substances that are synergistically involved in producing laetrile's beneficial effects.

It is almost impossible to design a double-blind study to find out whether combinations of those different elements: colon cleanse, kidney cleanse,

dd to the challenges in developing combination products:

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

liver/gallbladder cleanse, dietary supplements, exercise, meditation, exercise, massage, acupuncture, oxygen therapy, juicing, love, support, etc, really cures cancer because double-blind studies are designed only to determine whether one or few therapies work. Th

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

e lack of consise science in the approach of holistic medicines and the multidimensional characteristics of the diseases and the therapies at work makes it difficult to be clear which therapies are effective.

In a world where logic reigns supreme it is difficult t

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

o explain a therapy or treatment that has no logical explanation. For example antibiotics are designed to kill bacteria both good and bad in the body. Garlic kills bad bacteria but allows good bacteria to flourish! How do you explain that. Many alternative therapie

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

s cannot be easily explained with logic, they however do have intuitive appeal. The one size fits all approach of conventional medicine is designed to provide a solution to a particular symptom regardless of the underlying causes. Holistic medicines however, are

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

Professional from academic institutions, pharmaceutical industries, health care indust

often individually suited for every single patient. The many patients you have, that's how many therapies you are going to get. What caused the symptoms of one person may be entirely different to what caused it for another. Just like the cancer diet. You have as ma

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

ny individual diets as you have individuals. They can not be evaluated as one single therapy.

Holistic therapies take a WHOLISTIC APPROACH. It takes the workings of the mind, body, and spirit together. We still do not have a science to evaluate this. In other word

.

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

s, most natural programs for curing cancer can not be proven effective by the same means as conventional therapies. Breaking programs in separate pieces and evaluating every single piece individually rarely yields positive results.

Normally, it takes the FDA about

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

Companies that provide selfless information through particip

10 years and cost up to $250 million for a new cancer drug takes to be approved. Many drugs are well researched and marketed in other countries, but remain unapproved by the FDA in the U.S. This sadly is also true for a number of the alternative natural therapies.

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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