The era of the GLP-1s has ushered in a whole new paradigm to the treatment of disease and medicalization of patients. As you may have seen in the news in the past several months, GLP-1 drugs (e.g., Ozempic, Rybelsus, Wegovy, Zepbound, Trulicity, Victoza, etc.) have dominated sales figures, with major players feverishly expanding capacity and building new facilities to meet the spiking demand. Sure, we’ve seen blockbuster drugs in the past, but what’s materially different now with this class of drugs is that the demand is being driven by patient requests for prescriptions, including patient behavior modified and elicited by social media and countless “success stories” about the drugs’ effects for weight loss.

It’s not that this couldn’t have been predicted, and in fact, it was a short mental leap from the GLP-1 drugs’ initial approvals to treat diabetes, to reading the fine print in the clinical trials showing that many of the study participants had modest to remarkable weight loss during the trial period. Historically, drugs that have successfully lowered bodyweight have done well on the market, though many were pulled due to adverse safety events. That the GLP-1s are so effective at what they do isn’t the real news story, but that the direction of the doctor-patient relationship has so upended due to a variety of factors.

Doc, I need a prescription for X

Since the advent of ancient medicine, patients would seek care from a physician to be told what it was that ailed them. We’ve come a long way from the idea of disease being postulated to be caused by imbalances in the four humors—blood, yellow bile, phlegm, and black bile. The word “humor” in this historical case was translated from the Greek χυμός (chymos) meaning “juice.” Nevertheless, this idea is known to have roots growing earlier than c. 510 BC, and it lingered until around the 17th Century—running in-parallel along with the idea of “miasma” (bad air) as a cause of disease—until the Germ Theory of Disease (1850s, Pasteur, Koch, and Snow) attributed certain illnesses to microbes.

But a constant throughout in the practice of medicine has been that the diagnosis, however incorrect or off-base it may have been (or may still be!), was made by the physician, who then would prescribe a treatment for the relevant condition (medicine, food, fresh air, exercise, or otherwise). In a process-flow sense, the directionality of prescribing has always been:

Patient reveals condition > physician evaluates >
diagnosis > prescription

Now what’s been an incredible change in the practice of medicine is that it is looking more-and-more like this:

Patient hears of a condition on social media > checks the ultimate source of medical authority (Google) >
schedules physician appointment > requests prescription from physician for the treatment heard about on social media

So, the doctor-patient relationship has become one that’s more about seeking a solution (prescription) to a question that’s potentially still poorly understood (or nonexistent), rather than one of fact-finding and differential diagnosis to determine a proper course of action.

Patient-centricity and PROs

At the same time, global regulatory agencies are becoming increasingly concerned with topics such as representative demographics in clinical trials, patient-centricity, and Patient Reported Outcomes (PROs). These are in large part good advances, which bring the patient’s voice much more into the discussion about clinical efficacy and safety.

But like any change, it presents a difference. A difference in how clinical trials are conducted and evaluated. And the more weight is put on patient-centricity, the more we see medical schools teach classes on “shared [clinical] decision-making,” and the more emphasis is put on patient input and feedback. Taken to an extreme, this leads many physicians to lament that many of their clinical practice hours are now spent “undoing” the tangled threads that Google has created in a patient’s mind or talking patients out of prescriptions that they’re showing up to their appointments requesting. As is often the case amidst change, the right answer is probably somewhere in between these two diametrically opposed approaches.

Why this matters for outsourcing – and the industry

Many sponsor companies outsource their clinical trials to FSPs and CROs, and with good reason. But those organizations are also at the vanguard of these changes, and so are having to navigate paths yet unproven. At the same time, the rapid pace of the rise of AI/ML in drug development (molecule screening, epitope mapping, in silico developability, manufacturability, etc.) is impinging upon regulatory reviewers, and resulting in many cases in more complex drug targets, targeting systems, and therapies themselves. This makes outsourcing partners even more crucial in the contemporary landscape than they have been—and they’ve already been pivotal over the past few decades.

Navigating the path to approval is becoming more technically challenging, as well as fundamentally more complex and multifaceted than ever before. Remember, it’s not only the drugs that are getting more complex—in fact, but the irony is also that GLP-1 drugs are based on an incretin hormone which isn’t particularly new or novel. But the intersection of the drug, the patient angle, nascent technologies, and the regulation of them, represent a more complex overall system with more interdependencies than ever before.

This is making certain predictions more difficult, such as drug candidate pipeline success forecasts, for example, which has an impact on funding decisions—either internal budgeting or with venture capital or private equity. So, the very advancement of the industry to its current state may be what’s hindering further advancement of the industry in several very real ways.

As Albert Einstein opined, “The significant problems we face cannot be solved at the same level of thinking we were at when we created them.” Too true. 

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Ben Locwin writes the Clinically Speaking column and is an industry executive. He has worked both on the sponsor side and outsourcing side, and has been involved with several industry initiatives and changes in Health Economics and Outcomes Research, patient-centricity, PROs, as well as using technology solutions for drug discovery and development (like generative AI, ML, etc.) through appointments to working groups, committees, and task forces. He is the Keynote for Contract Pharma’s 2024 Annual Conference & Expo in New Brunswick, NJ.