Drug safety regulation need not be a jagged edge on which patients catch themselves

Off to Liverpool today. I am chairing a session at the Pancreas Society’s first ever PPI forum. This is the opener to their annual scientific meeting which takes place the rest of the week.

Last Friday was another first. I spoke to, and took part in, the inaugural meeting of the MHRA’s ( Medicines and Health Products Regulatory Agency) patient group consultative forum.

Is that the sound of broken shards from a glass ceiling I can hear beneath my feet? Let’s not tempt fate eh?

What else connects Liverpool to our drug regulator?

Well, just a few days ago in Liverpool, the Medical Research Council (MRC) and Sense About Science launched a new public guide on drug safely entitled: ‘Making Sense of Drug Safety Science: Investigating the science of side effects.’ And an excellent publication it is too in talking about side effects and how we are doing more to learn about them. You can find a copy here: http://www.senseaboutscience.org/pages/health-and-medicine.html

But there is more to this issue than increasing public understanding and awareness.

In my experience, drug safety is one of those issues where doctors, researchers and patients are a long way from reaching a satisfactory working relationship.

At root is the clash between ‘scientific evidence’ and ‘patient experience’ with the validity of the latter often disparaged. Typically this is couched in terms of ‘the hierarchy of evidence.’ It is an argument intoned with the same sort of words and feeling that we used to hear from members’ clubs about why it was necessary to exclude women.

We had such a question about ‘evidence’ versus ‘opinion’ to the patient panel from the floor of the ABPI conference last week. I also heard those arguments played out at the MHRA meeting but thankfully with good grace and a willingness on both sides to listen. The resistance to listen and respond is the jagged edge of regulation on which patients often cut themselves.

I am not sure that any patient or patient group is seriously trying to unseat the place of science in regulation. But I do hear them urge that regulators use different instruments according to the environment and context – as pilots do when flying in good weather or bad – to allow the patient voice to be heard more clearly. The same goes with doctors.

If seems foolhardy to me if regulators and the professions do not embrace the ‘informal’ yet undoubted richness of conversations that patients have about their medicines. And we have already seen with some drugs such as statins how the patient voice has been critical in changing practice and attitudes. Or in devising new tools like the medication passport developed by the North West London CLAHRC. If only the system might turn to such creative minds to develop a more patient-friendly yellow card system for reporting adverse events. We might get rid of forms for a start.

With vision we might see patients as an integral part of the regulatory system for improving drug safety. Not the inert mass to be protected.

Yes, regulation might just be the thing for them to cut their teeth on.

At least we are now at the table.

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