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Medicine is without a doubt one of the top most humanitarian and highly paying jobs that are out there. Doctors are experts of health and an integral part of the community and society. They are also high social status members of the community and are considered to be people whose opinions are worth money if not g

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

old.

Having been brought up in a medical background, I was convinced that medicine is my natural path in life. My medical training began in the Kingdom of Saudi Arabia which due to the multiple issues of women’s and humans rights I will leave out of this talk. But, let’s just say it took a lot of dedication and 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

ick skin to get through medical school there.

I was eventually granted a scholarship in the field of Anaesthesiology and came to Halifax, Canada, for my specialty training. Let me step back here and mention a fact I have found to be true no matter where you go in this world to practice medicine.

- Medicine was,

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

is and will continue to be an old boys club; the degrees of severity may vary depending on the specialties chosen. I remember being told that women who want to have babies and families should not become doctors and should be librarians...this is in Canada!

- Medical residency training is in many ways comparable 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

o military training as it is structured to

challenge the physical body, mental mind and emotional status over a course that may be as short as 2 years or as long as 7 years.

- Residents are the lowest of the lowest in the medical profession ladder; they are over worked, underpaid and ground to the bone. I remem

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

Combination pro

er working all night placing epidurals in labouring women as my staff anesthetist slept in the duty room as I fill out his billing forms for him to collect before he went home in the morning as I staid to finish up work.

- As residents (specialist in training) we are expected to endure abuse in many strange form

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

and not many of us are able or willing to speak out without being kicked out of the program we are in or at least suffering extensive repercussions. To say we have no rights is an understatement.

Having said all that I should also state that generalization is dangerous and there are exceptions I am sure. Rememb

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

er I am an X resident, meaning I have discontinued my residency training. Since I have done that I have filed a report to the humans right commission about the racial discrimination, sexual , physical and verbal assault, lack of support and mental and emotional abuse I have been witness and subject to in my resid

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

ncy training.

Not many people understand what it really means to take the challenge of trying to become a specialist. In my experience, unless you are a cold hearted and extremely rigid and tough personality the residency training will most definitely be a short and traumatizing road.

People wonder why the most

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

eveloped nations are approaching a crisis in the medical profession due to lack and shortage of physicians. As a result the workload doubles and in some cases triples on the existing ones.

An example that shocked me was increasing the pay of doctors who are willing to work after a full day of call (24 hr shift).

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

eaning encouraging doctors who have worked a full 24 hrs straight with little or no sleep to manage and care for sick people and their lives the next day. When a resident gets tired after a full 24 hr shift and starts to display signs of poor concentration or judgement they are not sent home, which the rules are a

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

Following aspects would a

gainst, instead they are humiliated and made to feel incompetent and given poor evaluations, and this is normal, common practice.

Another shocker was the overall female to female hostility that would range from passive aggressive behaviours from the superior female (usually a specialist, senior or nurse) towards

dd to the challenges in developing combination products:

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

he more junior female to cases of frank assault that are brushed under the carpet of residency training. In My case I had failed an entire rotation after being verbally attacked by one of the much older and erratic female operating room nurses in the middle of an emergency situation, I was labelled "Inappropriate

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

or leadership roles" by the same well respected Anesthetist (mentor) who was witness to the entire incident.

As residents we are not expected to have a life outside of the hospital, we breathe, eat, sleep and entirely drown ourselves with hospital work and if your wife is having a baby or your son is sick....well

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

then tough luck. And on top of that, you are not permitted to get sick either, but if you do ...well then you are nothing but a non- dedicated slacker.

Hospitals are also known to be some of the most sexually charged and frustrated environments any one can be in. A typical O.R day in my experience includes sexua

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

remarks or jokes flying back and forth as the surgery commences which I found embarrassing and shameful to be in. My overall personal experience to achieve my honourable goal of helping people has left me jaded and questioning the entire medical profession. Why is this being tolerated and why are those who try t

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

Professional from academic institutions, pharmaceutical industries, health care indust

explain the defects viewed as abnormal and not team players?

I wish I could say that having made a decision to leave medicine upsets me but I cannot. I am very happy to have disengaged myself from the scandal that is called residency training which ultimately produces defective and damaged physicians who would

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

only repeat history.

As I end this I would like to stress on the fact that I am not launching an attack on the medical world and I am not generalizing by any means. I am only stating the facts that I and many others know to be true but few develop the courage to talk about.

Medical specialty training as is will

.

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

ail and will continue to produce marginally moral and humane doctors until radical changes take place. Until the powers to be start facing difficult facts and correcting the old boy’s ways of thinking there will always be someone like me who just could not take it anymore speaking.

In the end I do wish every med

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

Companies that provide selfless information through particip

cal student and resident luck. May you succeed in what I have failed at, and may you bring the winds of change to life.

Those of you who would like to know what I did for work since I stopped my medical specialty training, I Have started my personal health and wellness home based business and am blissfully happy

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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