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"Neither a man nor a crowd nor a nation can be trusted to act humanely or to think sanely under the influence of a great fear." (Bertrand Russell)

Myrmecophobia, phalacrophobia, hobophobia, acrophobia, pentheraphobia, hypengyophobia,

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

venustraphobia, ailurophobia, gamophobia, ophidiophobia, arachnophobia, hydrophobia, alektorophobia, philophobia, logophobia and testophobia*. Do you have these symptoms for any of these? If you do, you are likely to be a normal human.

Fear is a com

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

Examples of combination products may in

on and dictating aspect of human behaviour. It is such a common reality to be afraid, that we have literally hundreds of words describing a particular fear which someone has reported suffering from. There are enough words to create a Phobia Dictionary

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

In this article, we will analyse the underpinnings of fear, an impressive (and often disconcerting) human emotion.

What is Fear?

Fear is mainly a physical response. The hypothalamic-pituitary-adrenal (HPA) system in the human brain

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

is loaded with dopamine and adrenaline, which are chemical messengers from the body. In a 'danger situation', the HPA releases these messengers along with a hormone (cortisol) which in turn activates the amygdala (an area of the brain responsible for

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

Combination pro

emotional responses, including fear conditioning). This reaction results in increased blood pressure, sugar availability, and an energy boost that allows humans to perform quite amazing displays of strength, reaction, and awareness in confrontational

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

ituations.

Because these chemical reactions occur before we have had the opportunity to consciously interpret the event, at times it can negatively impact upon our life. For instance, you may be walking in a dark street at night, and hear a loud nois

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

. Before you actually evaluate the situation and assess the danger, your brain will access data from the hippocampus (brain area responsible for memory) and determine instant readiness to the situation. In this scenario, you may take an impulsive move

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

or make a bad decision. Thus, fear is seen (particularly by males) as a sign of weakness and a negative trait.

The Foundations of Fear

The causes of fear can vary to a surprising extent. They may be originated from a stress respons

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

e which is related to a traumatic event from the individual's past; it can be a socially-motivated fear; or it can be a biologically-induced one. An example of a traumatic event would include a stressor, which is mainly a noise or image associated to

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

n event that has incurred a personal trauma. Thus, people who are afraid of snakes will usually react with fear when they hear a noise which resembles a snake (naturally this interpretation will depend on the context).

A socially-motivated fear can b

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

Following aspects would a

caused by a relationship between an event and its outcome. For instance, during the 19th Century in Britain, dying poor and helpless, was considered one of the most common fears. Early in the 20th Century, this shifted to the fear of being buried ali

dd to the challenges in developing combination products:

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

e. During the 1st World War, bombs were much more 'scary' than during the 2nd World War.

Finally, biologically-induced fear refers to predispositions in our genes, due to evolution, which makes us prone to fear something. There have been studies whic

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

h relate xenophobia and racism to behaviour from the Stone Age period, explaining why people naturally tend to shun outsiders.

Fear Counselling

As we've previously stated, fear seems to be a negative trait perceived from the eyes of

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

common sense. But is it really? Although we cannot change the way our body physically responds to a threat, we can change the way we emotionally respond to our body. This becomes a strategy to avoid trauma, distress and bad decision-making when faced

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

ith the adrenalin pump that fear creates.

The basis of exploring the positive side of fear is changing conditioned behaviour. The inability to react positively in a state of fear is due to a memory associative process, in which the individual cannot

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

Professional from academic institutions, pharmaceutical industries, health care indust

ee past negative outcomes which could occur. For example, a person who has a fear of heights will not be able to climb a tree because they will constantly enforce the idea of free-falling and getting badly hurt (or even dying). The problem is not in t

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

he sensation of fear, but in the association of the emotion and a negative outcome.

Cognitive restructuring techniques such as Thought Stopping and Rational Emotive Therapy are common methods used by counsellors to alleviate fears and barriers. Creat

.

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

ng awareness and willingness to change is a crucial part of the counselling process, and can determine the turning point for the client - the moment of surpassing fears, and approaching success.

* Fear of... ants, becoming old, beggars, heights, moth

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

Companies that provide selfless information through particip

r-in-law, responsibility, beautiful women, cats, marriage, snakes, spiders, water, chickens, falling in love, words and taking tests.

© Australian Institute of Professional Counsellors

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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