We all have heard of pharmaceutical research and clinical trials that build toward a new drug being released in the market. The miracle portions that tumble out of this multi-billion dollar industry is staggering. It is estimated that the cost for developing a new drug until release would be in the range of about 1 billion USD (this titbit is disputed however!).
The process of drug development may be essentially chemical (a chemical compound that is created for medicinal usage) or biological (extracted from living cells, e.g., antibiotics). Once a drug's efficacy is ascertained (technically speaking Lead Identification and Optimization procedures would be employed), safety and toxicology testing begins and the duration of each of these stages vary depending on the nature of the drug and understanding of the drug family, as well as its ultimate purpose and usefullness. Needless to say, the more the market value of the drug the more stringent the testing procedures, the more advanced the trials and the higher the quality standards adhered to. The conventional phases of pharmaceutical research in clinical trials include:
- Phase I and Phase II clinical trials, which examine the acute, dose-related toxicities of new drugs as well as the drug efficacy to an extent. While Phase I is usually conducted on healthy subjects Phase II is restricted to humans with specific diseases. However, Phase I clinical trials now increasingly include persons with specific diseases in whom all conventional therapy has failed (e.g., terminal cancer or AIDS); these would be termed as mixed PhaseI/II studies in this case.
- Phase III clinical trials primarily examine the pharmacological efficacy and the short-term toxicities—of new drugs to a degree.
- Once a regulatory agency approves a new drug (FDA - Food and Drug Administration - for drugs marketed in the U.S), pharmaceutical companies may conduct additional studies such as Phase IV clinical trials. These are post-approval surveillance studies on the long-term efficacy and toxicity of already-marketed drugs.
As we mull over all the information overload not to mention the statistics, we are faced with that usual question - exactly what is the role that 'ethics' plays in clinical research? Is it ethical to conduct Phase III trials and double-blind studies? Does this border on an unassuming patient being used as a laboratory guinea pig? Is one of the principal precepts of medicine - the concept of Primum non nocere - which means "First, do no harm" merely a myth? Do the biggies in the industry such as Pfizer and Merck consider the ethics in the issue of clinical research?
Perhaps ethics is an oft-discussed topic, especially owing to the controversy surrounding the issue. One can go to any extent quoting some authority on the area or reveal the extensive documentation on the studies conducted to support the reasoning of medical research. But the question remains unanswered. How much of the reality truly comes out in the open? How much is ethical and when is this border breached? is it a question of morals alone or one of survival?
Too many uncomfortable questions right? Yes, ignorance is truly bliss!
