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Getting Medications Right

With bird flu sweeping the US and swine flu taking its toll across India, influenza is a hot topic right
now and there has been a lot of focus on just how well we are prepared to tackle a full scale
pandemic, should the worst come to the worst. Whilst antiviral medications exist to ease the
symptoms of flu, and there are various vaccines designed to offer protection against contracting the
flu virus, there is no one single cure and the regular mutations of the flu virus make it very difficult to
counter. But with the human race able to eradicate smallpox through effective vaccination, and the
last recorded case being 1977, why are we unable to find a similar solution to do away with influenza
once and for all?
Aside from the fact that regular mutations of different flu strains make it incredibly difficult to
protect against, there is also the fact that the process of researching and developing new
medications is incredibly drawn out. In fact, the time taken to bring a new drug to market can take
as long as 20 years from inception to distribution, so what exactly goes into this process and causes
it to take such a long period of time?

Contents
Identifying Where the Need Exists ......................................................................................................... 3
Ensuring a Drugs Safety ......................................................................................................................... 4
Performing Clinical Trials ........................................................................................................................ 5
Seeking Further Approval ....................................................................................................................... 6
Embracing the Route to Market ............................................................................................................. 7
Conclusion ............................................................................................................................................... 7

Identifying Where the Need Exists

Rather than mix up concoctions at random to see what effects theyll have as perhaps an alchemist
might, the major pharmaceutical companies of the world do in fact have very in depth and heavily
scrutinised processes for the development of new medications, and these processes begin with
assessing medical need. Naturally the pharmaceutical industry has been seeking that elusive cure for
cancer for as long as the human race has recognised its existence, but there are any number of
conditions, minor and major, that could be the recipient of the next big breakthrough in medical
science.
When you consider that the British discovery of Sildenafil, commercially marketed as Viagra to treat
erectile dysfunction, has brought in revenues surpassing $1bn a year it is easy to see why these
pharmaceutical companies have so much to gain from being first on the scene with a revolutionary
new product. Although in the case of Sildenafil it was originally being developed as a treatment for
angina, before chemists realised its potential as what is now one of the worlds most marketable
drugs.

Ensuring a Drugs Safety

Naturally pharmaceutical companies have to be incredibly careful when it comes to the testing of
potential new medications and before the trials stage can begin, with medical volunteers, approval
must be granted by the appropriate regulatory body. In the US this is the Food and Drug
Administration (FDA) whilst in the UK approval must be sought from the Medicines and Healthcare
Products Regulatory Agency (MHRA). These regulatory bodies will perform stringent reviews of the
test medications compound structure, which in itself can be a very long and drawn out process.
If a drug doesnt meet the very strict safety requirements as demanded by the regulator then the
pharmaceuticals company must start again, potentially losing 3-4 years of work in getting their
product to this stage. No clinical trials will be conducted and the compound is consigned to history.

Performing Clinical Trials

The next stage of the process is getting the new drug to trial in humans. Volunteers will act
as guinea pigs to test the effects of the proposed new compounds, often being
compensated with money for their troubles. Test subjects can earn several thousand
pounds in certain instances, depending on the level of risk and the nature and length of the
study. Although the regulatory body will have had to have approved the drug as safe
enough to be tested on humans, there is always going to be an element of risk and there are
of course occasional high profile incidents where clinical trials have had disastrous
consequences such as the Northwick Park Hospital trial of 2006 that left six men in intensive
care.
During these clinical trials many of the compounds that make up the test drug will be
routinely rejected and on average less than 10% of all the tested compounds will ever
progress beyond the trials stage. For a successful trial to take place it can involve thousands
upon thousands of test subjects and it can last for as long as ten years in some cases.

Seeking Further Approval

The regulatory bodies who previously had to approve the drug for testing in human
volunteers will now have to review the findings from the clinical trials stage. There can be
no doubt as to whether or not the proposed drug is both safe and effective in the treatment
it is due to provide, otherwise it will not gain approval to be rolled out nationwide. Once
again this is a lengthy and protracted process, with different regulatory bodies having their
own criteria on what is required before approval is granted. This can take as long as eight
years as the regulators ensure that there can be no risk associated with the new product
and it has no unwanted long term effects.

Embracing the Route to Market

Whilst getting to this stage has taken a long time, perhaps as long as 20 years from the test
drugs original inception, the next phase can advance at a far more rapid pace. The approval
from the regulatory body gives the green light for the drug to be unleashed on the buying
public, but during the time awaiting this approval, the pharmaceutical company will have
refined its manufacturing processes so as to make it as economical as possible to mass
produce and distribute.
The complicated distribution process that is required to bring a new medication to the
registered pharmacists around the country, and indeed the world, involves specialist
pharma logistics companies who can precisely control the temperature required to keep the
medication at its optimal condition whilst transporting it. They will also need to be
incredibly secure so as to prevent theft, as prescription drugs can have a very high value on
the black market.
In Conclusion:
It is because we are so adamant in our desire to be safe and controlled that the process of
bringing a new drug to market can be such a lengthy affair, but there is no denying that it
works. Were we to take less time and care over the process thered be far greater risks
involved and its a risk thats just not worth taking.

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