Advice Pool - Health and Fitness

Patients suffering from eating disorders binge on food and sometimes are both anorectic and bulimic. This is an impulsive behaviour as defined by the DSM (particularly in the case of BPD and to a lesser extent of Cluster B disorders in general). Some patients develop th

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

ese disorders as a way to self-mutilate. It is a convergence of two pathological behaviours: self-mutilation and an impulsive (rather, compulsive or ritualistic) behaviour.

The key to improving the mental state of patients with dual diagnosis (a personality disorder pl

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

Examples of combination products may in

s an eating disorder) lies in concentrating upon their eating and sleeping disorders.

By controlling their eating disorders, patients assert control over their lives. This is bound to reduce their depression (even eliminate it altogether as a constant feature of their

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

ental life). This is likely to ameliorate other facets of their personality disorders. Here is the chain: controlling one's eating disorders controlling one's life enhanced sense of self-worth, self-confidence, self-esteem a challenge, an interest, an enemy to subjugate

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

a feeling of strength socialising feeling better.

When a patient has a personality disorder and an eating disorder, the therapist should concentrate on the eating disorder. Personality disorders are intricate and intractable. They are rarely curable (though certain asp

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

Combination pro

cts, like OCD, or depression can be ameliorated with medication). Their treatment calls for the enormous, persistent and continuous investment of resources of every kind by everyone involved. From the patient's point of view, the treatment of her personality disorder is

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

not an efficient allocation of scarce mental resources. Also personality disorders are not the real threat. If a patient with a personality disorder is cured of it but her eating disorders are aggravated, she might die (though mentally healthy)…

An eating disorder is b

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

th a signal of distress ("I wish to die, I feel so bad, somebody help me") and a message: "I think I lost control. I am very afraid of losing control. I will control my food intake and discharge. This way I control at least ONE aspect of my life."

This is where we can

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

nd should begin to help the patient. Help him to regain control. The family or other supporting figures must think what they can do to make the patient feel that he is in control, that he manages things his own way, that he is contributing, has his own schedules, his ow

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

agenda, matter.

Eating disorders indicate the strong combined activity of an underlying sense of lack of personal autonomy and an underlying sense of lack of self-control. The patient feels inordinately, paralysingly helpless and ineffective. His eating disorders are

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

n effort to exert and reassert mastery over his own life. At this stage, he is unable to differentiate his own feelings and needs from those of others. His cognitive and perceptual distortions (for instance, regarding body image – somatoform disorders) only increase his

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

Following aspects would a

feeling of personal ineffectiveness and his need to exercise even more self-control (on his diet, the only thing left).

The patient does not trust himself in the slightest. He is his worst enemy, a mortal enemy, and he knows it. Therefore, any efforts to collaborate wi

dd to the challenges in developing combination products:

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

h HIM against his disorder – are perceived as collaboration with his worst enemy against his only mode of controlling his life to some extent.

The patient views the world in terms of black and white, of absolutes. So, he cannot let go even to a very small degree. He is

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

HORRIFIED – constantly. This is why he finds it impossible to form relationships: he mistrusts (himself and by extension others), he does not want to become an adult, he does not enjoy sex or love (which both entail a modicum of loss of control). All this leads to a chr

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

nic absence of self-esteem. These patients like their disorder. Their eating disorder is their only achievement. Otherwise they are ashamed of themselves and disgusted by their shortcomings (expressed through shame and disgust directed at their bodies).

There is a chan

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

e to cure the patient of his eating disorders (though the dual diagnosis of eating disorder and personality disorder has a poor prognosis). This – and ONLY this – must be done at the first stage. The patient's family should consider therapy AND support groups (Overeater

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

Professional from academic institutions, pharmaceutical industries, health care indust

Anonymous). Recovery prognosis is good after 2 years of treatment and support. The family must be heavily involved in the therapeutic process. Family dynamics usually contribute to the development of such disorders.

Medication, cognitive or behavioural therapy, psycho

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

ynamic therapy and family therapy ought to do it.

The change in the patient IF the treatment of his eating disorders is successful is VERY MARKED. His major depression disappears together with his sleeping disorders. He becomes socially active again and gets a life. Hi

.

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

personality disorder might make it difficult for him – but, in isolation, without the exacerbating circumstances of his other disorders, he finds it much easier to cope with.

Patients with eating disorders may be in mortal danger. Their behaviour is ruining their bodi

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

Companies that provide selfless information through particip

s relentlessly and inexorably. They might attempt suicide. They might do drugs. It is only a question of time. Our goal is to buy them time. The older they get, the more experienced they become, the more their body chemistry changes with age – the better their prognosis

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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