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In the shadows

November 12, 2019
Life sciences

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Throughout history, there are countless examples of people who have toiled away without receiving the plaudits they deserve. During his life, Vincent Van Gogh couldn’t find a single buyer for any of his paintings, Andrew Ridgley (the other guy from Wham!) is always referred to as the ‘other guy from Wham!’ and – let’s be honest – has the inventiveness of President Donald J Trump’s hairdresser ever been fully appreciated?

Sweeping statements aside, the ‘unsung hero’ tag can certainly be applied to the more unfashionable and maligned corners of pharma. Add to that the thousands of patients involved in clinical trials, and you’ve got a vast crew of medicine development superheroes – all existing under a broad cape of modesty and reservation.

This specific lack of recognition from the wider public, many of whom take one or more pharmaceutical products on a daily basis, emanates from our brilliant, but impossibly complicated, UK healthcare scene. Over the years, layers of governmental changes – combined with mind-boggling industry regulation and a 71-year soap-operatic marriage between pharma and the NHS – have formed a sort of infrastructural filo pastry, through which it is impossible to see anything in sharp focus.

The consequence has been an inevitable apathy, even obliviousness, among the public about where medicines actually come from. It’s why most folk do not leap in the air with clenched fists, chanting the names of pharma personnel, when they receive their prescriptions.

In every other walk of life, however, British people have become a nation of unapologetic celebration addicts, with embarrassingly undemanding criteria for celebrating. And yet, there are no open-top bus rides for the pharma employees who uphold the integrity of a medicine’s efficacy, while the brave patients who put themselves through clinical trials are not carried shoulder-high through the streets.

Life and death

Within the life sciences labyrinth, many atriums lead to unsung heroes. Pharma folk across the country carry out essential jobs, but couldn’t be further from the limelight. Frontline manufacturing employees are perhaps the most notable example.

Tony Cordrey, vice president of European Strategic Operations at Accord Healthcare, knows only too well that performing these roles takes considerable reserves of character. “Most people have no idea about the preparation these people go through, and that’s before they even start doing their jobs,” he explains. “Tremendous changes over the last 40 years have resulted in much tighter regulations, and frontline manufacturing staff do most of the heavy lifting when it comes to maintaining the standards required to provide safe and effective medicines. There’s also immense pressure – the slightest mistake could result in a recall and, at worst, it could be fatal.”

During the manufacturing stages, in order to minimise any risk of contamination, teams work in hyper-sterile environments called ‘clean rooms’ – even cleaner environments than surgery theatres. There are strict procedures that everyone must follow, such as wearing protective gowning, covering hair, removing make-up, jewellery or watches and ensuring hands are repeatedly disinfected. “People are the biggest contaminating presence,” says Tony. “By simply standing there, a human releases 100,000 particles every minute. In a clean room scratching is not permitted and if someone sneezes they are required to leave the room, at which point the cleaning starts all over again.”

It’s safe to say, if you want to eat a club sandwich at your desk and style your hair in the reflection of your monitor, these are not the positions for you.

The packaging and delivery systems also reach levels of intricacy and meticulousness that would rarely enter anyone’s sphere of consciousness outside industry. Pharma companies have a legal obligation to ensure that whatever the delivery mechanism for a medicine – whether it is a tablet in a blister pack, a glass syringe or a vial – it must maintain the approved regulatory standards for that medicine’s efficacy, from the moment of creation until the last day of its shelf life.

“We ensure that the active ingredient is protected against degradation or impurities, and kept at the right temperature,” reflects Tony. “You might think that when a medicine leaves the plant we just begin producing the next batch, but we actually monitor every step of the product’s journey, all the way to the patient, nurse or surgeon.”

Tony notes that visitors are always amazed at the processes undertaken before anyone can even get near a product. Indeed, the most profound evidence of the benign force driving pharma’s frontliners is its unique brand of self-motivation, accompanied by an acceptance that superhuman levels of endeavour and concentration won’t be greeted by the public pyrotechnics of other industries.

“A person working in our manufacturing plant said to me the other day, ‘sometimes we don’t always understand why we are here, but we are here for the patients’. I was blown away that a junior member of our manufacturing team had so accurately pinpointed our purpose,” recalls Tony.

We could be heroes

The most courageous and unheralded groups on a medicine’s intricate mission to market are the cohorts of patients which form the vital human element of clinical trials; the groups whose individual and collective biological armoury can breathe life into a medicine – figuratively and literally.

Duncan Arbour, Senior Vice President, Insight & Innovation at Syneos Health Communications, is in no doubt about the contribution these patients are making. He insists: “The real unsung heroes of the pharmaceutical industry, and the most worthy of celebration, are indisputably trial participants. During clinical trials – ranging from MS to headaches – they endure incredibly uncomfortable and painful procedures.”

The role of patients in positively changing the lives of other patients is regularly confined to a footnote in the story of a treatment and, yet, without seeing a therapy through the prism of human experience there would be no pharma industry. “The commitment and willingness of clinical trial participants to put up with everything from the hassle of regular travel, to the real risk of harm in the event of a non-optimal treatment regime, is truly impressive,” says Duncan.

Heroic status is also reserved for those people in pharma who are blazing a trail for even greater patient input – such as sponsors and contract research organisations. These teams are edging the influence on product design – particularly in the vital latter stages – further towards trial patients. It is, however, an uphill struggle.

Changing of the guard

Duncan is brutally honest about the relentless flim-flam around increased ‘patient engagement’ and ‘patient-centricity’. He wants to see the emergence of something patients can believe in: “For all the talk, and all the shiny PowerPoint presentations, data from an Applied Clinical Trials survey in 2017 suggested that only four out of ten companies seek any patient involvement in study or protocol design.”

“Most patient ‘engagement’ in the trial process is simply a euphemism for sending dosing and appointment reminders,” he adds. “We need to allow advocacy partners and engagement managers to translate clinical materials into something warmer and far less, well, clinical. This is what the average person can relate to.”

Clearly such people are attempting to change some very entrenched cultures, but Duncan believes that they can emerge from the shadows. “They’re easy to find, if you know where to look,” he enthuses. “You’ll find them applying behavioural science and softer people skills, rather than statistical science and logistics. They’ll be looking to turn information and data provision into a two-way street, and doing the hard and often thankless work of practising real patient-centricity, rather than simply preaching the theory from conference stages.”

Folklore pharma

We love to recall the tale of Sir Alexander Fleming, who in his haste to go on holiday neglected to tidy his lab and, on returning, realised his rank untidiness had yielded penicillin. Meanwhile, in the extraordinary film, Dallas Buyers Club, we watched in awe as anti-hero Ron Woodroof, recently diagnosed with AIDS, demanded access to unapproved drugs, defied the FDA and revolutionised the concept of patient control.

It seems we can appreciate heroes of pharmaceuticals or altruism, but only in retrospect. The heroes of progressive pharma, however, always exist in real time and until patients are more empowered, employees are better understood and therapeutical milestones are played out in the present, the wider population will always be in a state of reflection.

In the final analysis, pharma deserves more heroes. It would be great to see the pharma equivalent of MasterChef, with lab-based contestants given ten years to prepare a viable treatment for a life-threatening disease, but I suspect it would run into complications well before Gregg Wallace was handed a capsule and a glass of water.

The truth is, most people involved in treatment – at the development or trial stage – don’t court fame, popularity or deafening applause for their rendition of a Whitney Houston song. They’re in it to extend, transform, change, enhance or save lives. If they achieve any of those things, it’s mission accomplished.

By John Pinching

Source: Pharma Times

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