Friday 3 November 2017

Fast-track approvals and Hippocrates - an old problem revisited

The UK news today announced government plans to fast-track drugs through the approval process (see this article from the BBC).

It is true that the approvals process is arduous and hugely costly. In a 2014 report examining the approvals process through different divisions of the US regulator, the FDA, the difference between the slowest and fastest divisions for median approval time was 400 days, i.e. over a year. It comes as little surprise to neurologists and people suffering neurological problems that the slowest was neurology and the fastest was cancer and antiviral drugs.

A significant risk of rushing things through is that vital safety signals get lost. In cancer, where a last-ditch drug might extend survival by a few weeks or months in a rapidly progressing fatal condition, these risks may be outweighed by the benefit given. However, in neurological diseases such as Parkinson’s disease, where people live with the condition for decades, even small risks must be given much greater weight. The chances of complete cure are low, and the number of patients that may be treated with it are much higher.

The Hippocratic oath instructs the physician to “First do no harm”. While we all strive to find the silver bullet for conditions such as Parkinson’s disease, motor neurone disease and so many others that cause such distress and suffering, we must ensure that we do so safely and effectively. We depend on a rigorous regulatory system to protect the public, but also to examine their processes and ensure the costs (both financial and opportunity costs to patients) are kept to a minimum.

RNR

NB these opinions are my own. We're keen to hear yours - please comment below.

For a very eloquent summary of the dillemas facing the FDA and how the fast-track process relates to neurology I recommend this article from the Lancet Neurology



Does neurology need a faster FDA?
Adrian Burton

The Lancet Neurology, 2014 vol 13(8) pp760-761.

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