THE NEW ERA OF MEDICINE

in ARTICOLI

The new Era of personalised medicine was born as a reaction to the “One size fits All” Medicine that treated in the same way different illnesses and patients with failures and adverse reactions to drugs. As there is not one shoe that fits all feet and not one size that fits us all, we need individual shoes – medicine.
The revolution moved in three steps and it began in the 1930s with the era of incidental discoveries such as aspirin and penicillin – medicine that helped without researchers knowing how and why they worked. The second revolution started in the 1970s with new experimental methods and systematic screenings to finding chemical cures. The last step began in the early 2000s with the end of the human genome project and is now localizing medicine to a personal level.
Today Medicine uses new approaches to better manage patients’ health and target therapies to achieve the best outcomes in the management of a patient’s disease or predisposition to disease.
The disease is treated in the context of the patient, that is a world of proteins, of emotions, a family one.
Since the first sequencing of the human genome in 2000 ( at the cost of 1 billion dollars each) only 16 years have passed, and today we can have the genome of a person in a few hours and with a few hundred dollars, with a more precise profile of a person and a better treatment.

By submitting DNA we are submitting very special informations.
At that point we will know every thing about that person: their illness and the best treatment but also we will know their future. So we have to be very careful and know who can have access to these data, who should use them and those who report them.
This is a very important issue: the security of data, the consent and the privacy arrangements for patients are paramount. If we do a mastectomy of a patient with mammal cancer and after we tell her that she is bearing a gene that predisposes her to have cancer on the controlateral breast too, should we advise her to undergo mastectomy? Ovariectomy? To tel that to her daughters? In many situations of our lives lack of knowledge and uncertainty are unbearable. In the field of medicine it’s often the opposite as certainty can sometimes have the devastating effect of a landmine; whereas not knowing what is written about us in the book of life is an important factor of stability. This is an explosive issue that cannot only be of interest to the scientific world because there are also bio-ethical, social, religious and political issues of great relevance.
Definitely we have entered the New Era of Medicine of The four ‘P’s
Predictive, Preventive, Personailzed, Participatory

Predictive
Until now individual care has been based on medical diagnostics, the study of family history, social circumstances, environment and behaviors. Now we have the genome but the genome isn’t the whole story. It is the basic script, we need to go further on to the proteins, which are the machines that make us who we are; the proteome is doing the job and it might be changed by living standards, stress, food and plenty more. We have learned a lot about epigenetics in the last ten years, which means that genes are the basic script but, which genes are active or not changes through our lifetime and it is some kind of reprinting on a second layer above our genes. Although16 years have passed after the sequence of the human genome, we still have a quantity of information but not much the ability to interpret it.
Preventive
Using genomic technologies and other diagnostics we will be able to identify people most at risk of disease even before the onset of their symptoms. Earlier detection will open up the prospect of new treatment options and support people to make informed lifestyle choices.This will create the potential to reduce the growing burden of diseases, particularly for long-term conditions such as c.v. diseases, cancer, chronic respiratory diseases and diabetes. As regards man’s expectations from techno-medicine for the “length of life, without diseases”,

we cannot create illusions and that even if we can prolong our life, in nature there are no “free lunches” and everything has a price. We have to recall that, even if life is 30-40 years longer, the price to pay is the higher incidence of cancer, cardiovascular and neurodegenerative diseases. The burden of these diseases will not be sustainable for long because people will be so old that it will not be possible to cure all of them. The economies of the countries, even the richest ones, will be affected by the ageing of the population.
Personalized
We are all unique. Personalised medicine offers the opportunity to move away from ‘trial-and-error’ prescribing the optimal therapy the first time round.Currently key pharmaceutical treatments are effective in only 30-60% of patients due to the differences in the way a person responds to, and metabolises medicines. The knowledge of the genetic variants at the basis of individual drug response can be used to create an individual’s ‘pharmacogenomic’ profile, identifying optimal treatment. We can strengthen our ability to design appropriate health and care for our local populations through a more sophisticated understanding of the impact of age, gender and ethnicity or lifestyle factors that influence the onset of disease. This will enable us to be far smarter in the way that we manage and leverage the limited resources that we have.

New partnerships will be central in driving forward a personalised medicine approach – bringing together clinical practice, academic rigour, industry skills and the active involvement of patients and patient groups. Personalised medicine has advantages for individual patients, for populations, for science and for the wider economy.
Participatory
Medicine wil be more and more participative with the patients who will take an active part in their therapy. It is not the time anymore when the doctor could say to the patient “I am the doctor, trust me...” Today, thanks to the information that the patient can access, doctors can transfer more and more responsibilities to the patients and their relatives. The ability for a clinician to discuss with their patients information about individual genomic characteristics, lifestyle and environmental factors, and to interpret personal data from wearable technology will drive a new type of conversation. They can consider lifestyle changes, and when treatments might not be necessary. It might also lead patients to consider preventative measures when there is high likelihood of a disease developing.This is a new era of medicine and it requires new knowledge amongst professionals, patients and the public to have confidence in using the information available to them.
Especially in the current globalized society where different stories, colors, religions and cultures mix together.

We have to take into consideration different parameters; we have to approach every single individual in a very discreet way, depending on their real requirements. We can’t possess other people’s diseases and needs. Rather, every patient must be involved personally in the treatment they are given and, above all, they must be free to accept it or refuse it.
At this point i’m glad to rimind you that the general and founding principles are stated in documents like the Convention on the Rights of Mankind and Biomedicine (1997) Oviedo and its related “additional protocol on research”, and also in the “Universal Declaration on Human Genome and the Rights of Mankind of Unesco (1996) ( United Nations Educational, Scientific, and Cultural Organization).
The text of the Oviedo Convention declares: “The signatories parties of this Convention protect the Human Being in their dignity and identity and ensure every individual without discriminations the respect of their integrity and of the the fundamental rights and freedoms regarding the applications of Biology and Medicine. The interest and the wellbeing of human beings must prevail over the main interest of Society and Science.
The text of the UNESCO Universal Declaration on Genome declares:

art.1) the human genome implies the fundamental unit of all the members of the human family as well as the recognition of their intrinsic dignity and their diversity. symbolically it is heritage of humanity.
art.2) every individual is entitled to the respect of their dignity and of their rights whatever genetic characteristics they have. such dignity imposes not to limit individuals to their genetic characteristics and to respect the unique character of each person and their diversities.

Let’s take as an example the Familiar Hypercholesterolemia (FH) which causes raised cholesterol and a significant risk of heart attack and other cardiac events in the under 50s. It affects 1 in 250 people – but only 1 in 6 of these are diagnosed. By systematically using both genetic and biochemical testing, FH can be identified and affected people can receive inexpensive medicines to protect them from future

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