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Does Evidence-Based Medicine Need More Rcts?

By Terry Maguire - 17th May 2022

Admitting A Mistake, Terry Maguire Acknowledges That We Need To Be More Supportive Of The Work Of Community Groups At Grass Roots Level.

I spent — potentially wasted — eight years of my life serving as a member of Belfast Local Commissioning Group (LCG); the last two years in the chair.

LCGs were one of those bodies that spin-out from grand government shake-ups of healthcare structures where the people doing the shaking-up forget to close down other bodies doing more or less the same things, so they lack any clear role budget or power.

There were five LCGs across N Ireland, meeting monthly from around 2008 until 31 March 2022 — they will stay on in some shadow form until another largely pointless body with a new set of ideologies takes over their reigns. I am of course being much too cruel and cynical, as the Belfast LCG did a lot of great work for the city.

The role of the LCG was to apply evidence-based solutions to improve delivery of healthcare for the local population. Healthy Hearts in the West (HHW) was an innovative programme focused on reducing the behaviours that cause and worsen the main killer diseases — heart disease, respiratory disease, and cancers.

HHW had a strong focus on pharmacy, as we provided weight management services and smoking cessation services. The LCG one-stop ophthalmic service allowed access to eye consultants in a community setting and greatly reduced waiting lists for glaucoma treatment.

This service stopped people going blind. Our redesigned stroke services allowed rapid access to a stroke specialist, so the damage done by brain bleeds or clots are addressed in a timely fashion.

Plenty of success to make a noise about and quietly, I am proud of my involvement, but the downside was always the politics. I was invited, with other past chairs, to the final LCG meeting and to say farewell to its highly talented LCG lead, who was retiring.

Before the kind words and the cake-cutting, there was the usual monthly meeting. It is five years since I occupied the chair, but the business, the issues and politics were strangely familiar and irritatingly predictable.

Reliable data from clinical trials should be how we decide which interventions to fund

We heard from a community leader about a multidisciplinary team (MDT) programme for co-ordinating ‘social prescribing’ through community development organisations.

This was the old challenge I knew well; trying to bring together and making use of myriad community groups allegedly providing services across the city, yet with no evidence of benefit.

These groups, mostly singleissue organisations, vie for recognition and funding and only after that do they consider what it is they might do for the health and wellbeing of the good citizens of Belfast.

They end up offering Tai Chi, reflexology, aromatherapy or cups of tea to ‘the pissed’ on a night out in Belfast City Centre.

They all believe their services are transforming the health and well-being of the local population. Commissioning must be evidence-based.

For the services these groups provided, that was a struggle. Getting this point across diplomatically was difficult, frustrating and political.

They were good at politics because that was the core of their being. LCG was accused of not providing services (ultimately funding the services they had to offer) and if we did provide the services, we were accused of not providing proper access.

When we assessed these services and found them ineffective, we were accused of using the wrong methodology. As chair, I had a simple ask from services we funded; just support people to stop smoking, to lose weight, to take more exercise, and to manage stress.

In this way, public health is improved, and the evidence for this is pretty strong. ‘Nonsense’; I was told it was much more difficult and complex than that.

Poverty and social deprivation and the wider determinants of health, and the complex interactions of these, is the problem. ‘No’, I argued, people just needed to stop smoking… So, thinking I knew what evidence-based medicine was, this was one of the issues that caused me to eventually leave LCG, as it reconfigured evidence for community development to support funding.

I felt justified, smug almost, as I listened to this social worker at the final LCG meeting struggling to describe, quantify and justify a pilot model and what health benefits it could have when funded city-wide. I was less smug when, a week later, I read a BMJ paper which opined that most evidence-based medicine is a sham, as it has been corrupted by corporate interests, failed regulation, and commercialisation of academia.

Reliable data from clinical trials should be how we decide which interventions to fund. But most clinical trials are conducted by the pharmaceutical industry and then reported in the names of senior academics.

More importantly, the clinical trials necessary to show the most effective interventions will not be funded, as Big Pharma does not see a profit. Confidential pharmaceutical industry documents seen by the paper’s authors give a worrying insight into the degree to which industry-sponsored clinical trials are misrepresented.

We have been tricked by an industry whose first priority is profit. The integrity of science and the role of science in an open, democratic society is where practitioners do not cling to cherished hypotheses and take seriously the outcome of the most stringent experiments.

This ideal is, however, threatened by Big Pharma, in which financial interests trump the common good. The BMJ article is pretty direct and hard-hitting.

Ownership of data and knowledge by Big Pharma suppresses negative trial results, fails to report adverse events, and does not share raw data with the academic research community. This has always been a concern and one that has not been properly addressed.

The authors claim that patients die because of the adverse impact of commercial interests on the research agenda. There is increasing evidence of this malpractice, certainly in the available data to support the marketing of many medicines; SSRIs, statins, opioids and testosterone. In depression, for example, the evidence base for the effectiveness of SSRIs in the treatment of mild-to-moderate depression shows these drugs to be only as good as placebo.

Long-acting opioids were marketed as less addictive than immediaterelease versions as the evidence-base produced by the Sackler company-sponsored clinical trials and promoted by their generously funded key opinion leaders showed this, but it has resulted in half a million US deaths and counting. The BMJ authors accuse Big Pharma of having a greater responsibility to its shareholders than the common good.

Universities have always been elite institutions prone to influence through endowments, and the recent Sackler debacle is testimony to this. But in more recent years, particularly in the face of inadequate government funding, academic institutions have been forced to actively seek pharmaceutical funding. Those of us who spent any time in academic posts know all too well the pressure to get such funding.

Ghost-writing of medical journal articles and continuing medical education are the means by which academics become agents for the promotion of commercial products. I was wrong. LCG was right to support community development and I now realise that it opened up for me a more holistic and societal view of healthcare and wellbeing. We need to be more supportive of the great work all community groups do at a grassroots level.

I now wonder, for example, if the football coach bringing a group of teenagers onto a cold, wet pitch on a Wednesday night for football training might be doing a lot more to reduce the suicide and drug addiction rates in the future than I have done over the last 40 years dishing out antidepressants. This is a question that will probably never be answered with a double-blind, randomised, controlled trial.

CONTRIBUTOR INFORMATION

Terry Maguire owns two pharmacies in Belfast. He is an honorary senior lecturer at the School of Pharmacy, Queen’s University Belfast. His research interests include the contribution of community pharmacy to improving public health.

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