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Anorexia is a troublesome disorder characterized by an obsession with weight and food. With a target group consisting primarily of adolescent girls (80-90%), the anorexic will crave food, but will refuse to eat or retain it because of an overwhelming fear of weight gain. The indivi

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

dual may stop eating almost entirely, and will deny that her behavior is abnormal and that health is deteriorating. Typically, the anorexic will say that “she feels fat,” even when she is obviously underweight.

The behavior of the anorexic may be characterized by a pattern of socia

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

Examples of combination products may in

l withdrawal, rigorous exercise, and ritualistic eating habits. The emotional profile of the anorexic is marked by a pattern of depression, fear of obesity, and loss of self-confidence. Physical symptoms include a loss of menstruation and a weight loss of up to 20-25% of body mass.

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

According to diagnostic criteria, a female patient is clinically suffering from anorexia nervosa when body weight has fallen to 15% below normal and she has not menstruated for at least three months. The same body weight criteria apply to male patients.

Anorexic teenagers are gen

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

rally unwilling to receive treatment, resisting any attempts at counseling. Those who reluctantly seek treatment begin the process from an adversarial perspective. Developing a collaborative relationship with an anorexic patient is no easy task. It is critical that the therapist de

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

Combination pro

velop a warm, friendly, honest and accepting relationship with the anorexic. The quality of the therapeutic relationship will be a factor in determining the individual’s willingness to deal with the terrifying aspects of eating and weight gain.

The relationship provides a means for

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

examining cognitive distortions and maladaptive underlying assumptions that the anorexic applies to her internal world. It is critical that the counselor accepts the individual’s beliefs about body perception as genuine for her. Any attempt to refute, challenge, or devalue the per

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

son for holding erroneous assumptions about weight and body misperception is counterproductive. Anorexic teens are used to hearing from significant others that their beliefs are illogical and irrational.

It is the goal of the therapist to enter into a mutual fact-finding process wi

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

h the anorexic client. By accepting the patient’s belief system as genuine for her, it is possible to introduce doubt about the anorexic’s basic cognitive assumptions. The individual may be encouraged to reexamine core assumptions about the value of thinness. Several lines of inqu

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

iry might be, “Is it practical for you to embrace this idea?” or “How does losing weight fit in with other values that you cherish?” Emphasizing that treatment will follow an experimental model is an important notion. The therapist’s approach with the anorexic might be, “Let’s try

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

this out and see what happens.”

Therapy with the anorexic involves challenging faulty thinking and beliefs. For example, if the patient expresses apprehension around the issue of losing competence if she gains weights, the therapist can help her develop a working definition of comp

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

Following aspects would a

etency that will establish a concept of whether or not it is influenced by weight changes. Such questions such as, “Would you appreciate your friend more if she weighed less than you?” may help cut into the double standard established by the anorexic patient.

Questioning the anorex

dd to the challenges in developing combination products:

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

c about what would happen if their worst expectations came to pass may minimize the imagined effects of the event. The person who demands “thinness” is obviously anxious when she considers herself “fat.” The counselor may inquire, “What’s the most horrible thing that could happen i

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

f you were to gain weight?”

Cognitive distortions are numerous in the anorexic and must be gently challenged. Distortions such as dichotomous thinking, (“If I gain weight, I’ll be considered obese.”), overgeneralizations, (“I will never get any better and my eating will never impro

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

ve.”), magnification, (“Gaining any weight will be more than I can take!”) must be directly, but gently confronted in counseling. The anorexic is encouraged to design experiments to test the validity of specific irrational thoughts. For example, the anorexic individual may be encou

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

raged to interview her friends for preferences in physical appearance, checking out how often people select a friend based exclusively on the merit of weight.

Body-size misperception is a significant feature of the anorexic disorder. The individual may be asked to reinterpret what

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

Professional from academic institutions, pharmaceutical industries, health care indust

he sees. Such counter-arguments may involve the use of reattribution techniques such as, “When I try to estimate my own dimensions, I am like a color-blind individual attempting to create my own wardrobe. I will rely on other’s objectivity to assess my actual body size.”

With the

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

anorexic, maintaining a multidimensional approach to treatment is necessary, focusing on information processing, cognitions, and other strategies such as:

• Dealing with family issues. Some therapist’s believe that the anorexic disorder actually acts as a stabilizing force for 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

family.

• Dealing with personal goals and ambitions of the anorexic.

• Focusing on issues of control, perfectionism, assertiveness and autonomy.

• Dealing with social adjustment issues.

• Assisting with problem-solving and coping skills.

Dealing with the anorexic patient is dema

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

Companies that provide selfless information through particip

nding and requires flexibility and creativity as necessary ingredients if the therapeutic process is to be successful. Many anorexic clients struggle with their body misperception issues throughout their life and may need to revisit the counseling process during times of high stress

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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