Rise of Medical Misinformation and Need for Expert Medical Writers

The theme of this year’s American Medical Writers Association conference was “Rise, Reflect, Reimagine,” – an apt theme given the current climate in the biotech industry, the rise of Artificial Intelligence (AI), wildfire-like spread of medical misinformation in social media, and general distrust of traditional sources of information. This conference brought together like-minded medical writers who are passionate about safeguarding against misinformation and disinformation to ensure accuracy before clinical trial data reaches the regulatory review process. 

Here are my reflections relevant to early-stage product development and regulatory writing. 

Trust but Verify – A Whole New Level 

Generative AI is currently part of the cultural zeitgeist with ChatGPT becoming a popular substitute for a Google search. Google even has an AI mode. But how accurate are the results, and how can you validate the accuracy?  

Take a topic you’re intimately familiar with and observe the veracity of the results. Many have observed hallucinations performed by generative AI, as far as citing journal articles, webpages, or even court cases that simply do not exist. And that review is just based on one’s own knowledge.  

That’s not to say that AI doesn’t have its place; it does. But AI, like any number of other things, is “garbage in, garbage out.” It requires intentionally crafted prompts, inputs that are clear and consistent, and well-defined discreet tasks. Most importantly, it needs an expert to double-check the outputs. Unfortunately, that’s not how the public uses ChatGPT or Google AI, and many are blindly trusting the results.  

It can be very difficult for experts to dispel the myths that generative AI propagates, with general users lacking the resources or education to evaluate the outputs. However, trained medical writers work within rigorous quality control frameworks to validate sources, verify citations, and work to prevent AI-driven inaccuracies and compromising information, creating submissions that are audit defensible and trustworthy with regulators, investigators, and patients. 

Recipe for Misinformation 

Pair the rise of generative AI with a general distrust of traditional information sources, and it becomes a recipe for misinformation and disinformation. It’s clear the public no longer trusts the pharmaceutical industry, or in some cases medical professionals. They feel unheard and dismissed, leaving a window for the spread of potential disinformation, as opposed to those who simply lack the resources to verify information before reposting misinformation. This, paired with the current climate of the industry, high turnover and a general feeling of uncertainty, adds fuel to the fire.  

So, what can we do as an industry? While those promoting questionable practices like vaccine hesitancy are effective in convincing people to act against their best interest, such tactics are often unethical, and even in some cases illegal false advertising. Scott Ratzan, Co-Chair and Editor-in-Chief of the Nature Medicine Commission on Quality Health Information for All spoke about this topic, noting that there is something effective in their approach.  

To counter, facts don’t necessarily change minds when they’re presented without empathy or understanding of the human burden of disease, especially those with chronic illnesses. Those spreading disinformation know how to spin a story, while projecting the image of listening to patients.  

Patients want to be heard, and we need to ensure that medical information is conveyed in a scientifically sound, but accessible and understandable manner that acknowledges their physical medical needs, as well as their logistical and emotional concerns. This theme was carried into another discussion by Dr. Jen Gunter, who spoke about the misinformation around menopause and hormone replacement therapy that is rampant online. 

Early-Stage Drug Development and Regulatory Writing Considerations 

You may be wondering how this insight applies to early-stage product development and regulatory writing. 

It’s important to remember that the information gathered from both nonclinical and clinical studies ultimately guides the label, and eventually the summaries that are provided to patients. The verbiage used in Module 2 summaries will be carried onto the label, directly reaching patients who are likely to read the package insert.  

Using clear, concise language for regulators will make the process of translating for a lay audience go much more smoothly, ensuring no informational gaps. By engaging with experienced medical writers, sponsors can reduce downstream rework and ensure translation accuracy since well-crafted Module 2 summaries are built to be label- and patient-ready.  

Putting the Patients Back in the Center 

In addition, several sessions were dedicated to recentering patients in clinical trial development. As one speaker pointed out “how much will the patient care about an improvement in lab values if they’re miserable with nausea taking the drug?” Patient advocacy groups, especially for chronic or rare disease, can guide protocol development to ensure sponsors are measuring the parameters patients care about, the things that affect their day to day lives, in addition to the accepted regulatory endpoints. Furthermore, patient advocacy groups can help spread the word of promising effective treatments, helping with trial engagement; nurse advisory groups can also provide insight into the patient’s experience from a medical provider’s perspective.  

We also need to remember the burden that participating in a trial can have on participants. While sponsors want to retrieve as much information as possible, and explore various pharmacodynamic biomarkers in addition to required safety and pharmacokinetic analyses, can we consolidate visits or blood draws to relieve participant burden? Are we explaining to participants what information we hope to gain and how their participation in things such as questionnaires and additional optional biopsies or imaging may help others suffering with their same disease? Are we paying attention to cultural or logistical concerns that may keep certain demographics, such as women or parents of young children, from fully participating in clinical trials? We all know that gastrointestinal adverse events tend to diminish over time as the body adjusts to the medication, but we still see significant noncompliance and trial dropout due to these issues. Are we effectively communicating to participants that these may be temporary? Are we providing enough guidance to investigators on management? And once the drug is on the market, are prescribing physicians communicating this to their patients?  

These are the kinds of questions my team and I reflect upon. 

Focusing on the vision of our industry – improving patient health through the development of new treatments – is the first step in ensuring effective communication with regulatory authorities, patients, and public in the battle against medical misinformation and the effort to restore trust in the health system.  

Partnering with expert regulatory medical writers ensures clarity, compliance, and trust at each stage of product development, helping you deliver accurate, patient-centered communications from first-in-human studies through approval and beyond.  

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