Pharmaceutical industry
The pharmaceutical industry is a business sector dedicated to the manufacture, preparation and marketing of medicinal chemicals for the treatment and prevention of diseases. Their job, is to create pharmaceutical drugs to treat, prevent or cure disease. Drugs are classified in various ways, for example, the level of control with distinguishes prescription drugs( the ones that you need the order of a doctor) from over the counter drugs (the ones we can consume ourselves).
Product approval
In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) , in the case of Europe the European Medicines Agency, as being both safe and effective. This process generally involves agreement of an Investigational New Drug filing with enough pre-clinical facts to support proceeding with human experimentation. Following DNA approval, three phases of progressively larger human clinical analysis may be conducted.
- Phase II can include pharmacokinetics and dosing in patients.
- Phase III is a very large study of efficacy in the intended patient population.
Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk estimation, approval to market the product can be sold.
A fourth phase of post-approval supervision is also often required due to the fact that even the largest clinical doses cannot effectively predict the possibility of rare side-effects. In certain instances, its indication may need to be limited to particular patient groups, and in others the substance is removed from the market completely.
A product must pass the threshold for cost-effectiveness if it is to be approved. Treatments must represent 'value for money' and a net benefit to society.
Well, the ones testing any kind of new drugs that might be sold at the market one day are human, commonly callled, human guinea pigs (cobaya humana or conejillo de indias). This practise with humans, involves they’re exposed to several health dangers and permanent side effects. People who volunteer for these trials can be anyone, from a healthy student who needs to make a little extra cash to a desperate cancer patient hoping an experimental drug really can help.
Ads asking for volunteers are everywhere, on the backs of buses and on Craigslist. Te guinea pigs sign a consent insuring they are concious abot the risks, try the drug and are given money for that. In Spain, they are paid between 500 and 3000 euros depending on the centro de sanidad and the prueba.
This system was called into question last month when a clinical trial of a pain medication in France went horribly wrong. While the health ministry is still investigating what happened, five people were hospitalized and one volunteer died. All these volunteers started the study healthy and now some may leave with a permanent disability.
http://ethics.harvard.edu/pharmaceutical-industry-institutional-corruption-and-public-health
https://en.wikipedia.org/wiki/Drug_discovery
https://en.wikipedia.org/wiki/Drug_discovery
Investigation
At present the research in the laboratories of pharmaceutical companies focus their interest in finding improved treatments for cancer, diseases of the central nervous system, viral diseases such as acquired immunodeficiency syndrome (AIDS), arthritis and circulatory system diseases, which are the illnesses that mainly afflict developed countries, and ultimately, they generate more profit. Little research is done on the prevailing conditions of developing countries (eg Chagas disease in South America), because the return on investment in these markets is low.
The use of live animals in medical research is the subject of controversy. While pharmacists have developed and continue to develop techniques to prevent their use, live animals (mainly rats and mice) remain crucial for many procedures.
