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It's interesting how a discussion about vaccination can quickly become heated and sometimes even hostile. Would the same debate rage over an antibiotic or an antihypertensive medicine if there was evidence the drug was causing harm? When it becomes obvious that thousands ha

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

ve been injured by a drug such as Vioxx, it is removed from the market. We stop the use of drugs until they are proven safe. And we sue.

Not so with vaccines. Vaccines are promoted with fanfare until they are statistically proven to cause harm to a large number of persons.

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

Examples of combination products may in

he thousands of individuals who suffer from vaccine reactions in proportion to the millions who have been vaccinated are not considered to be a mathematically significant statistic. However, the more than $1billion that has been paid to vaccine-injured persons shows that sa

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

ety is not all that is it promoted to be. Why the double standard?

Vaccination is built around a "belief system." We believe vaccines are safe; we believe vaccines are important to health; we believe the stories that vaccines are solely responsible for the elimination of sm

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

llpox and polio. And we really want to believe that our doctors have read all the available information on vaccines--pro and con--and are telling us the complete truth about vaccines.

However, belief is based on faith, not necessarily on fact. For example, we want to believ

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

Combination pro

that vaccinating our children will keep them from getting sick with measles or chickenpox. However, there is a plethora of information documenting this is not necessarily so.

Why is there an almost desperate need to defend the current belief--and trust--in vaccines? The pu

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

lic’s view of disease seems to be similar to our current view on terrorism: Random attacks that are potentially deadly. The media hawks this view of childhood illnesses and the need for vaccines. Pharma sells it, doctors push it, and educational institutions reinforce it. T

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

ey keep selling it because most readily buy into it, without question. There is a "just in case" or "better be safe than sorry" mentality when it comes to vaccination and illness with children.* After nearly 200 years of use, fear still sells vaccination.

What do we really

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

now about vaccines? A review of the literature and the CDC documents reveals the following:

1. Vaccine safety studies are relatively small and include only healthy children. However when a vaccine trial has been completed, vaccines are given to ALL children, regardle

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 of the condition of their health, family history or genetics.

2. Vaccine safety studies are short. Most clinical trials monitor for side effects a paltry 21 days, sometimes, it is only for 5 days. It can take months before immune system complications appear. This a

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

bitrary deadline, established by the FDA, precludes associating vaccines with chronic health disorders. "Safe" is a designation given based on limited information.

3. Vaccine safety studies do not use a true placebo.One of the Gold Standards in medical research is th

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

Following aspects would a

"placebo-controlled" trial. An inactive substance such as a sugar pill is given as a placebo to one group of participants, while the treatment group is given the new drug. The data is analyzed to compare the number of side effects that occurred in those given the drug compa

dd to the challenges in developing combination products:

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

ed to the numbers of side effects that occurred in those given the placebo. However, the "placebo" used in vaccine research is not an inert substance such as sterile water; it is another vaccine. Inert, sterile water doesn't cause a reaction; as substitute vaccine can. If b

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

th groups of babies in a trial have the same number of reactions, the study reports that the vaccine "is as safe as a placebo." This is deceptive science.

4. Vaccine-induced antibodies do not correlate with protection. In fact, the esteemed journal, Vaccine stated th

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

s clearly "…It is known that, in many instances, antigen-specific antibody titers do not correlate with protection." The full reference can be found at PMID: 11587808

Vaccination has been accepted as safe, effective and protective. The shots can be described as a medical <

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

>"sacred cows," by definition, "a medical procedure unreasonably immune to criticism." The strong response is the a reaction to a suggestion that the "cow" should be "sacrificed." It is heresy to suggest that the status quo is wrong.

When Copernicus insisted that the su

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

Professional from academic institutions, pharmaceutical industries, health care indust

, not the earth, was the center of the solar system, it went against the philosophical and religious beliefs held during the medieval times. When two other Italian scientists of the time, Galileo and Bruno, embraced Copernican theory their comments were considered blasphemo

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

s. Bruno was tried before the Inquisition, condemned and burned at the stake in 1600. Thirty years later, Galileo was brought forward and in front of his "Betters," was forced to renounce his beliefs under the threat of torture and death. Even after his confession, he was se

.

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

tenced to imprisonment for the remainder of his days.

The more one investigates vaccination and studies the adverse effects that have been attributed to vaccines, the more one becomes a Copernican heretic, speaking out against the status quo can have deadly consequences. I

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

Companies that provide selfless information through particip

ave personally invested more than 8,000 hours in revealing the truth about vaccines. If the result of this inquiry and exposure is to be called a heretic, than I am in wonderful company.
____________________________

*My thanks to Judy Converse for these insights

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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