The BMJ has published a report criticising the way drugs are regulated in Europe
Silvio Garattini and Vittorio Bertele of the Mario Negri Institute for Pharmacological Research in Milan are critical of the dominance of pharmaceutical industry priorities in bringing drugs to market. They appeal for a more patient and doctor led priorities.
There are two common issues which doctors and patients have about prescription drugs – firstly, the drugs which are available often don’t work for individual patients, so there is always a desire for drugs which work better than the ones currently available; and secondly, drug company priorities are more market driven – they are more likely to fund research into drugs for developed countries problems than developing countries problems, even though many more people die from common diseases in those latter countries. The reason why the first problem is not addressed by the current system is summed up in the article –
New drugs have only to show they are of good quality, effective, and safe, independently of any reference or comparison to drugs already on the market. This results in overuse of trials against placebo. Even when new drugs are compared with existing treatments, the trials often seek to show equivalence or non-inferiority rather than superiority to those already available. Such trials could allow drugs into the market that are less active or safe than those in current clinical use. This is because the non-inferiority limit includes a higher incidence of adverse events. The wider the limits the smaller the sample needed and consequently the higher the chance of missing a difference and concluding for non-inferiority. Sometimes limits are so wide that what is considered non-inferior statistically may be worse clinically
They conclude
It is unethical to experiment on patients with the sole aim of obtaining a marketing authorisation. New drugs should be required to have some added value (greater efficacy or less toxicity) to current treatments or be cheaper
So true. This is a European perspective but exactly the same problems are present in the US. And what about the majority of people in the world? How could the system be improved to meet the most pressing health needs in the world, rather than just in developed countries?