In December last year I wrote the following paragraph as a post scriptum to the batch of Patient Voice articles that I wrote:

There is a difference amongst companies in how seriously they take the Patient Voice agenda. But I wonder what commitment there would be if there were no longer any regulatory pressures in place. Here is a thought experiment: let’s suppose that Trump 2.0 makes cuts to FDA that indirectly causes an unravelling of a raft of regulations and best practice guidance in relation to the Patient Voice, particularly in the area of diversity. Let’s suppose this undoing has an impact on the ability of FDA to assess submissions, where capacity may disappear altogether. The result is that patient voice initiatives are no longer expected or properly regulated. No more RWE research required, no more cognitive debriefing, or comprehension testing, or REMS or anything to do with patient safety or health literacy. In this new reality, how many CROs and Pharma companies do you think would still insist on Patient Voice research in drug development? How many sponsors would do it voluntarily? How many Patient Voice slogans decorating their conference booths? You would count them on one hand.

Prescient? Nah, everybody must have seen this coming. The unravelling of binding and non-binding guidance to do with the Patient Voice could well happen. It could happen unintentionally, or it could be a deliberate cut, where the executioners fail to understand the basic premises of something like Patient Voice research and assume it has some other agenda. After all, in their zeal to do away with any guidance relating to gender-based pronouns, they also killed FDA guidance around the use of pronouns when communicating to patients. This was not a document motivated by identity politics. All it did was advise medical writers to communicate directly to patients, using the pronoun ‘you’. This was instead of using constructions more traditionally employed in medical communication that avoid addressing the patient directly. This would include the passive voice or the third person ‘patients must take care to avoid drinking when taking this medicine’. Nothing ‘woke’ about it. It’s very sensible advice aimed to empower the patient. Yet, the scattergun (or scatter-algorithm?) approach has dragged this guidance up into the same net as what they perceive as the more controversial pronoun guidance. Maybe they are reviewing all that they pulled – as they say they are - and will restore it when they realise it is not on their kill list. I hope so.

Returning to the scenario of the unravelling of FDA guidance - and cuts and chaos and bottlenecks of submissions. It could be that nothing is submitted, or nothing is approved and nothing is done any more in terms of any kind of Patient Engagement and clinical studies are hobbled before they get going. In a free-for-all scenario of no rules or reduced rules, innovators may well seek a new home outside of the USA. Markets ultimately decide.

But in amongst all this is the ongoing human cost. I have written elsewhere about the course that typical small businesses take. All businesses grow and they all contract. Those that are still around have had just little more growth in relation to the contraction. Some companies might just be hanging on for dear life, while putting on a brave public face. Because you have to. When a person sets up a business, it is fuelled by hopes and dreams. Nobody says ‘I will try this for a few years and if it fails, it fails, then I will do something else’. Quite the contrary: any business represents the blood, sweat and tears of the founder and those around them. Behind every closed-down restaurant and every shuttered-up store is a small huddle of broken hearts.

Every employee is a business of one. You are your own ‘Inc.’ or ‘Ltd.’ Being laid off is exactly the same as a closure of a business. The same pain. In the USA, two hundred thousand broken hearts right now, maybe more. When it happens, you don’t think about the empathy and support you receive from loved ones. You cannot even look at them in the eye. An arm around the shoulder or a sympathetic word sends you melting into the ground. It takes a while for you to get back up again. You focus instead on the shame, the stigma and the schadenfreude – this is the real evil eye: there are some people who just do not want you to thrive.

Over the years, I have worked with lots of people from Competent Authorities – people who assess your submissions, approve your medicines and vaccines, make sure your food and beverages are safe to consume. Or Public and Global Health specialists that we will really need in the next health emergency – and there will be one. All the people I have worked with from FDA, to MHRA, EMA, BfArM, etc. are hard-working, talented, precise and extremely bright. I can assure Mr Musk that they do have neurones, and they do have pulses. In fact, the only time I suffer from FOMO is when I deal with them: I genuinely wish I was more like them. But it is not just their talent that I like about them. Think about it: Why are they drawn to the public sector in the first place? Because they are not motivated by money. Because they sincerely love what they do. Because they have ethics and integrity. And they don’t tend to chat BS.

Integrity and a lack of BS… These are not values that I see in spades in some of the dark corners that I have worked in commercially.

It could be that the public sector’s loss is the commercial sector’s gain. There will be thousands of people with expertise in health services research and the Patient Voice agenda – the real agenda, not the fake slogans I have been writing about in many articles thus far. My advice to anyone laid off from FDA or CDC or a similar body is: set yourselves up as your own businesses. Use your commercial contacts. Show the rest of the commercial sector exactly how Patient Voice research with integrity is done. You will come back brighter.

And then… partner with a company like us to give you an immediate international reach.

We, the bottom-feeders,

we, the purveyors of solutions that are low in prestige,

we, the providers of services that others do not want to do or cannot do

or that few understand,

we, the mopper-uppers,

beholden to nobody and employed by nobody.

We are ones who are free.

Come and be a bottom-feeder.

Thank you for reading.

Mark Gibson

Leeds, United Kingdom, February 2025