Summary - Health and Fitness

We only have to look at a Titian painting to recognize that at one point in the history of Western culture, fat was considered beautiful. Before the 20th Century, corpulence was touted as a sign of wealth and luxury, largely because most

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

people were barely surviving on a meager existence.

Ironically, now in our era of affluence and plenty, we have to contend with the health and economic problems of obesity. We have a population in North America that is more than 55% over

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

Examples of combination products may in

eight. More than 20% of those overweight are considered obese, a situation which proves to be an economic burden on our Health Care system because of the coronary risk factors associated with obesity. In 2004, total national health expend

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

iture in the USA was $1.9 Trillion or $6,280 per person.

Why is obesity a risk factor for heart disease?

Among obese individuals, triglyceride levels are unusually high, while HDL levels tend to be low; both of these situations are risk

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

factors for heart disease .A recent study involving tissues collected from autopsies of 3000 men (15-34 years old) who had died of external causes (not heart related) identified an association between obesity and coronary atherosclerosis.

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

Combination pro

Abdominal fat which characterizes obese individuals is also an area of concern. A study of 1300 Finnish men (42-60 years old) suggests that abdominal fat is an independent and major risk factor for coronary events. Several reasons have

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

een suggested for this: a) stomach fat is continually released into the bloodstream in the form of artery-clogging fatty acids; b) abdominal fat also releases compounds that facilitate risk factors such as atherosclerosis, metabolic syndr

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

ome and inflammation; c) abdominal fat initiates biochemical events that lead to insulin resistance, a precursor of Type 2 diabetes and heart disease.

Obesity is often a precursor to metabolic syndrome, a dangerous health situation that

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

s manifested through a cluster of symptoms—excess body fat, insulin resistance, low HDL cholesterol, high triglyceride levels and high blood pressure—all risk factors for coronary events. People with metabolic syndrome release immune syst

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

em messengers called “cytokines” into their bloodstream. Cytokines lead to a communication breakdown between body cells and insulin which leads to excessive insulin production by the pancreas, creating a situation that is a literal “time

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

omb” for heart disease . In addition, this excessive insulin production can raise fibrinogen concentrations in the bloodstream, thus allowing blood to clot more easily, a situation that is a direct risk factor for heart attacks and stroke

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

Following aspects would a

s.

Because of their size, obese individuals are more often than not sedentary in lifestyle. Inactivity in and of itself is also a coronary risk factor. Data from more than 88,000 women in the Nurses’ Health Study shows that a lean sedent

dd to the challenges in developing combination products:

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

ry woman had 1.48 greater risks for coronary heart disease than a slightly heavier but physically active woman.

However, the same study also showed that obesity alone is a risk factor, in fact, an even greater risk factor than inactivity

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

because coronary disease risk was highest for women who exercised the least and had the greatest waist-to–hip ratio. The conclusion that obesity itself is a risk factor is also supported by a study of 5881 overweight and obese individual

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

which showed that being overweight increased the risk of heart disease by 34%, while being obese increased the risk to 104%.

What can we do to help someone we know who is obese or dangerously overweight?

Acknowledgement of the problem

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

is the first step. Very often, individuals are in a state of denial about the seriousness of their weight situation. A visit to the doctor or a healthcare professional who deals with the morbidly obese is essential. So are visits to a nut

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

Professional from academic institutions, pharmaceutical industries, health care indust

itionist, fitness consultant and body work therapist. Only then can the individual be presented with options viable and necessary for his or her situation.

In severe cases of obesity, surgery would be part of the solution. Lifestyle cha

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

nges that include exercise and healthy eating are more than essential. Just as critical are bodywork therapies that can uncover some of the real issues behind addictive eating. Learning to read body cues of hunger, depression, stress is e

.

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

ually important for re-mapping a new life and a whole new cartography of food and consciousness, body and mind.

In Titian’s day, the corpulent body was an idealized figure on canvass, essentially exiled to the realm of the fantastic or t

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

Companies that provide selfless information through particip

he realm of the unjust in a society where hunger was the norm. In our days, the corpulent body has its own tale to tell: a Quasimodo that is both the scourge and product of a culture addicted to perfection.

Copyright 2006 Mary Desaulnier

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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