Professor Dame Sally Davies, the Chief Medical Officer for England and the most senior health advisor in government, has called for an independent review of the safety and efficacy of medicines.
The review, which started on 17th June, is being conducted by the Academy of Medical Sciences (AMS) and will explore how different sources of evidence (eg randomised clinical trials and observational data) are used to make decisions about the safety and efficacy of drugs.
The AMS is one of the UK’s six National Academies, and aim to promote medical science and its benefits for society.
Prof Dame Sally Davies said:
“There seems to be a view that doctors over-medicate so it is difficult to trust them, and that clinical scientists are all beset by conflicts of interest from industry funding and are therefore untrustworthy too.”
She cited debates over the use of cholesterol lowering statin drugs for people at low risk of developing heart disease, and doubts about the efficacy of the anti-viral oseltamivir (Tamiflu).
“I have, therefore, reluctantly come to the conclusion that we do need an authoritative independent report looking at how society should judge the safety and efficacy of drugs as an intervention.”
Dr Ben Goldacre, author and co-founder of AllTrials said:
“This is mixed news. On the one hand, there are many clear structural shortcomings in our efforts to implement the basic principles of evidence based medicine: from the prioritisation of research, to the running of trials, and on to evidence synthesis, dissemination, and implementation. The problem of trial results being routinely and legally withheld from doctors, researchers and patients is only one such issue. There is a huge amount of good quality evidence on these shortcomings; but there are also several positive, practical things that could be done to make medicine better. A good overview of this area – showing leadership and support for innovative solutions – would hugely improve patient care, and safety.
But there is a risk. In a worst case scenario, if these very real problems are seen to be dismissed by the Academy’s review, then that would make the problem of public trust even greater; it may also hold back efforts to fix the problems at hand. In light of this, it is disappointing that the Academy of Medical Sciences has not consulted its members and signed up to the AllTrials campaign as many other fellowship bodies have done. This would be a good sign that they see the necessity and urgency of addressing this simple problem. AllTrials signatories simply state their commitment to ensuring that all results of all clinical trials are made available to doctors, researchers, and patients. This is the basic minimum requirement for doctors and patients to make informed decisions about which treatment is best for them. There should be no barrier to any scientific or medical organisation giving this their unqualified support.”