KFunk said:
^ This is one of the reasonable arguments in favour of certain forms of regulation in my opinion. The average consumer can't be expected to have advanced knowledge of pharmacology or of the statistical interpretation of clinical trials. It thus makes sense to put in place bodies, like the TGA, which monitor the efficacy of available products. Naturally we want to iron out failings in this process and keep it as efficient as possible. Sometimes drugs do get held up for good reason though - some drugs are reported as being efficacious in the popular press even though such claims are based on studies with poor methodology. Regulatory bodies may be rightfully skeptical in such cases. On the other hand, I'm sure that the process also proves overly slow/cumbersome/conservative at times.
Suppose a company finally manufactures a cure for cancer today, having spent billions of dollars, years of effort in research and development.
The drug, instead of being freely traded from day one, is instead directed through the paper maze of the Food and Drug Administration, whereupon further trials are conducted to test for potential hazards it may pose to people's health. The director of the FDA, for fear of being the one responsible for releasing an unsafe drug, green-lights the standard procedure for gauging its safety. This process usually takes several years to complete.
There are two outcomes for this; either
- The drug is bad. It has severe side effects, such as death, in which case we can all thank the FDA for protecting society.
- The drug is good. In which case countless people suffering from cancer have been denied access to something that could have saved their lives – ironically "for their own good".
Surely, if one assumes that a pharmaceutical company is in it for the money, and that a dangerous drug does not sell well, then it's in the company's interest to make sure that part of the hundreds of billions of dollars in funding goes toward making the drug as safe as possible. You know, to make it marketable.
Don't you think the government's role in this area would be more effective in making sure companies are held responsible for mistakes when they occur, making the rogue manufacturers pay for the damage they cause, instead of impeding the supply of medicine to where it's needed? While it's true the average consumer can't be expected to make an educated interpretation of clinical studies, can't he rest knowing that the company that makes his medication relies on his health improving?