Summary - Health and Fitness

With a number of effective, low-cost solutions available for issues like anxiety, depression, insomnia, phobia and stress, why do they still affect so many people?

Anxiety combined with de

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

pression is the most common form of mental health problem. Research by the Mental Health Foundation suggests that one in four of the adult population of the UK will experience some kind of

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

Examples of combination products may in

ental health problem in the course of the next year. The National Office of Statistics show that 7.7% of the population suffer from the combined effects of depression and anxiety at any one

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

time. Additionally 3.1% suffer from anxiety and 2.1% from depression. That’s a total nearing 14%. Not surprising then that Richard Layard, chair of the Mental Health Policy Group reports 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

at “Crippling depression and chronic anxiety are the biggest causes of misery in Britain today. They are the great submerged problems, which shame keeps out of sight.”

The total cost of de

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

Combination pro

pression was estimated at ?3 billion per year costing the NHS ?420 million whilst only 2% of NHS expenditure was spent on tacking these problems. The National Institute for Health and Clin

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

cal Excellence (NICE) believe that people with anxiety and depression should be offered the choice of psychological therapy. This view is also backed by Richard Layard because in a study co

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

nducted by the Mental Health Foundation it was demonstrated that therapy is, in the short term, at least as effective as drugs and, in the long term, better at preventing relapse. No surpri

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

e then that the NICE guidelines recommend that everyone should have the therapy option made available.

But that’s simply not an option for those that need it most, as there are simply too

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

few therapists available. Those people choosing the therapist option would have to wait at least nine months or more before getting an appointment. So if they want to avoid taking prescribe

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

medicines, their options are limited to either private treatment which can be very expensive or ‘remote therapy’ from an online therapy site.

Perhaps this is why there has been a dramatic

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

Following aspects would a

rise in the private or self-help alternatives available. The last couple of years have seen a dramatic growth of remote therapy sites providing for psychological issues ranging from anxiety

dd to the challenges in developing combination products:

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

, depression, insomnia, phobia and stress. Try it for yourself, just google ‘psychotherapy, online, self help, UK’ and you’ll find sites like virtual-therapist.com which have become very po

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

ular in the last few years. Produced by recognised therapists, the sessions are recorded onto mp3 of pdf format and can be downloaded for immediate private use. Although not having the bene

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

fit of face-to-face interaction with a therapist, they do have the advantage of being able to be used over and over again whenever needed. For example, imagine a nervous person having the b

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

nefit an Anxiety Therapy that has been downloaded onto their mp3 player that’s instantly available for whenever an anxious moment surfaces. And it’s not just about convenience these therapi

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

Professional from academic institutions, pharmaceutical industries, health care indust

es are available for a fraction of the typical ?750 fee charged for a course of treatment by a private behavioural therapist.

Other reasons why these remote therapies may have become incre

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

singly mainstream is that they are anonymous, instantly available and surprisingly effective. Whatever the reason there is no denying that they very popular. Over the last year many of the

.

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

self-help therapy sites have reported a 300% increase in download traffic. It’s clear that self help therapy is fulfilling a need because even by NICE’s own estimates it would take at least

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

Companies that provide selfless information through particip

seven years to train all of the 10,000 therapists needed to fulfil the current demand.

It seems that for many that suffer with issues like anxiety or depression, this wait is just too long

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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