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E-Articles - Tough Love Approach Keeps Fad Dieting Going
Increasing numbers of waiting list patients are now being forced to slim before being allowed to have routine operations on the British National Health Service.
A newspaper investigatio
A newspaper investigatio
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 claims that the localised policy is now to be rolled out nationally by the end of 2007.
Doctors will allocate treatment to patients according to their Body Mass Index, the BMI being t
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
he formula relating putative optimum weight to height.
If people have a BMI over 30, which is commonplace in the UK and very much towards the average zone in the US, they will be denied
If people have a BMI over 30, which is commonplace in the UK and very much towards the average zone in the US, they will be denied
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
non-emergency operations such as hip and knee surgery, or procedures including IVF treatment.
The new guidelines already apply to about 1 in 15 of the PCTs in the UK and, when implemen
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ted nationally, the BMI-rule will affect about 1 in 5 of the population. Failure to achieve the threshold for operations will result in being recommended a crash slimming regime and reas
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
sessment after six months.
Health officials state that their rationale behind the strict new qualification for treatment is justified by research which shows that slimmer people have be
Health officials state that their rationale behind the strict new qualification for treatment is justified by research which shows that slimmer people have be
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
tter recovery rates from surgery. Whatever the proven scientific case for this viewpoint and also not forgetting the debatable validity of the now 150 year old BMI standpoint, a consider
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
ed critique reveals troubling implications within this clampdown.
One of the central paradoxes of the current major debate surrounding obesity is the question of why people persist in l
One of the central paradoxes of the current major debate surrounding obesity is the question of why people persist in l
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ong term dieting cycles when dieting is increasingly discredited as an effective means of lasting weight control.
It can be argued that individuals are being driven into fad dieting not
It can be argued that individuals are being driven into fad dieting not
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
so much by the long standing notion of Yo Yo Dieting (itself, we would contend, simpliste and flawed) but rather by overwhelming institutionalised and cultural pressures. From this pers
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ective, the creeping criminalisation of overweight, which is advancing steadily deeper and deeper into the denial of erstwhile civil liberties, is a major stepping-up of these institutio
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
nalised pressures.
Some would also argue that the extension of public health care intervention into wider and wider aspects of modern living is not so much a wellbeing aspiration as a s
Some would also argue that the extension of public health care intervention into wider and wider aspects of modern living is not so much a wellbeing aspiration as a s
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ymptom of the current western governmental drift towards an increasing micromanagement of the whole lifestyle.
This is not necessarily a claim either of the left or the right, as both p
This is not necessarily a claim either of the left or the right, as both p
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
erspectives would be critical of an excessively big state overriding basic liberties.
The problem with all of this in relation to the overweight arena is that it is leaving those alread
The problem with all of this in relation to the overweight arena is that it is leaving those alread
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
y involved in failed fad dieting with nowhere to turn except straight back into more fad dieting.
Gradual lifestyle adjustments, new coping strategies for the emotional stresses which t
Gradual lifestyle adjustments, new coping strategies for the emotional stresses which t
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
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
rigger overeating, a relaxed appreciation of the cultural drivers towards fad dieting cycles and the fostering of a choice to move in fresh directions – all of these healthful options ar
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e blown away by the official decrees to lose weight fast. In the absence of alternatives, what are people to do except to plunge back into the fad dieting mainstream?
Government, unchal
Government, unchal
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lenged, is always going to be relatively short term in its outlook; it is simply the way that it tends to work.
The short termism in this instance is exacerbating the very issues it is
The short termism in this instance is exacerbating the very issues it is
.
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
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
seeking to address. The macho “tough love” approach will do little except deliver “tough luck” on those problem dieters who now have less freedom than ever to break away from fad dieting
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
.
This is another expression of the growing yet implicit official view that the overweight are deviants who must be brought back within the correct moral line. Is this fair or accurate
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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