It is the era of Medical Science. Every now and then a new medicine, a new bio-molecule, a new cloned gene is discovered for improving the Health and Care systems available.
Obviously, the death rates are decreasing, and so are decreasing the pain and problems of patient. Humanity owes allot to science..
Bioethics means the understanding of ethical issues involved in biological sciences which arises due to the human involvement in biological experiments.
Because of high success of medical science, a patient now a day wants fast cure and least pain. The patient does not care about science; what he wants to know is can science cure him? As a result of the surge in seeking medical help for various ailments, the surge in market of new medical drugs is also uprising. Genetic engineering, and biotechnology is expanding faster than ever before and various monoclonal bio-molecules are being developed and tested for serving the human kind against deadly and painful diseases.
But, discovering and developing a drug is not easy. When a drug is identified to be helpful, it is tested initially in the laboratory and then it is used for tests on animals. Even after tests on animals, a new drug or bio-molecule cannot be said safe for human to be used as drug… The immunity system of human and animals differs allot and many a times, some bio-molecules and drugs don’t show much side affects on animals, but prove to be drastic on human. For that, after the drug is successfully tested on animals, it is tested on human in Clinical Trials.. Clinical trials are divided in four steps through which a new drug must go through.
First step: this is basically for testing if drug is safe for human body. The experiment is done on small number (less than 30) of healthy individuals. But if drug is suspected to be toxic it is used on patients. Various cancer drugs are first used on patients.
Second step: in 2nd step, the drug is tested on larger group of people, mostly patients, to distinguish the safety as well as the usefulness of the drug on patients. Third step: now the drug is tested on much larger group of patients (in number of several thousands), to register the efficacy of the drug and the trends it varies its effectiveness from patient to patient. Proper data analysis is done to compare with the effectiveness of drugs already present for the disease cure.
Fourth step: after third step, the drug is usually approved for use, still it is monitored for any later side-effects on the patients it has been experimented. And if some later effects are noticed, the drug can be prohibited from usage commercially.
On March 2006, a new humanized monoclonal antibody TGN1412 (also known as CD28-SuperMAB) was tested on six volunteers.
The test failed miserably and all of the six volunteers suffered extreme systemic organ failure. There were Many Lapses in that case which caused the failure and many questions were raised after that catastrophic disaster against the volunteers which created a need for objectivistic ethics which must be considered during such medical experiments. It should be noticed that Individual rights and bioethics must not be defied by new culture of the “knowledge economy” that prop ups capital creation above all else. It must be understood that wealth is not all above, but Individual rights are.
Many people may agree to be volunteers for the medical experiments for various reasons.
They or someone close to them may be suffering from the disease for which the new drug has to be experimented, and they want to help in it. Or some people may agree just for the money they will get as a result of the deal after the proper medical experiment. Or some people may just agree for the volunteer ship for such medical experiments for humanitarian and science cause. Some severely ill patients at death-bed (suffering from same disease for which medicine is being tested or some other disease)may also agree to volunteer.
For such medical tests, the voluntary sanction of the Individual is absolutely indispensable. That is, a person involving readily in a medical test for a new medicine should have lawful authority to give his consent and must not be underage. He should be able to use his free-Right of choice without any effective force, hoax, treachery duress, compulsion, over-reaching, emotional blackmailing or any other clandestine constraint or coercion. He Must Be Free to choose to be volunteer for a medical test if he wishes to. He should be provided full knowledge about the purpose of experiment, its duration, possible side-effects, pre-test reports on animals and all difficulties and vulnerabilities reasonably to be expected; and the effects upon his health which may occur because of his participation in test. It is right of the individual willing for volunteering medical test, and it is duty of the practitioner willing to perform the experiment to inform the volunteer his rights. Such medical practices, where the drug is suspected to be potentially harmful for human life, must be avoided as much as possible and such experiments must not be random or unnecessarily performed.
Such experiments must not be practiced where a priori reason to believe that death or permanent harm is inevitable to the volunteer, and during any medical experimentation, all unnecessary physical or mental suffering must be avoided. The medical practitioner should take care that the dangers involved in experiment must not exceed the levels determined by the humanitarian significance of the problem involved. Obviously, it is the right of volunteer to demand for best possible medical help during the experiments appropriate preparation and sufficient facilities should be provided to care for the volunteer against even remote possibilities of damage disabilities or demise.
An individual may voluntarily agree for letting himself to be a subject of medical experiment, but in no way he gives away his liberty to anyone at any stage. And he must be free to cull and end the experiment at any point during the course of medical experiment if he feels he has achieved the bodily or psychological state, where continuance of the medical testing seemed to him to be impracticable or unbearably painful or dangerous. He cannot be forced to continue the experiment. The scientist involved must remain ready to terminate the experiment at any stage if he himself discovers some dangers that the continuation of the experiment is probable to result in injury disability or death to the volunteer during the course of experiment.
Basically, it all can be dealt with proper contract system.
Science is a power, which must be dealt with care and prudence; it is to help Human and to develop the ways for the cure of human diseases and problems. Proper attentive approach must be taken for any medical science experiment involving human as experimental subject, so that the drug which is being experimented to test its ability to help human, may not become a cause of despair, injury, disabilities or death for those individuals who volunteer for drug tests.
Now, the question arises, who will decide or look after if the ethical lines are being followed or not. Basically, it doesn’t need any authority to control medicinal market, because the market will control it by itself. Any pharmaceutical company going to perform any medical test will make sure for taking proper Medical care of the volunteer by themselves, because if they won’t do so, any accident will ruin their market prospects and business. Also, with increasing awareness, the pharmaceutical companies will gain confidence of people to commit for volunteer ship.
So, in general there is no need for any forcible legal code for the experiments, yet the medical practitioners will keep spreading awareness about the clinical trial methods and safety involved.
And with improving techniques, the clinical trials will be made more safe and trustworthy in future.
The need for freedom for both volunteers and the medical companies is must for the development. The rights are the power of the aware Man who is actively willing to safeguard his Individual rights. An irrational person who is not enough attentive towards the Individual Rights he holds on the basis of reason can be easily victimized by some of the “money mongers” for whom rational ethics means nothing. It is not only right of the Individual who is willing to volunteer for a medical experiment of a new drug to know all premises of risks involved, but also, it is his duty to remove any chances of treachery or deceit.
Evil requires the sanction of the victim.
Ayn Rand