Crafting Standard Responses With Agility and Precision:
Tying it All Together
In the dynamic field of medical information in the biotech and pharmaceutical industry, standard response letters play a pivotal role. In my previous posts, I’ve provided insights into various aspects of medical writing, and today, I’m tying it all together by walking you through the process of writing a standard response on a nutraceutical known as ashwagandha.
You may wonder why I would focus on an unregulated, questionably efficacious, and potentially harmful dietary supplement. My reasoning includes the following:
- No Conflict of Interest: This area doesn’t overlap with my other work.
- Popular Product: Ashwagandha has recently gained significant attention in various circles.
- Clinical Studies Exist: Unlike many nutraceuticals, clinical studies exist. We will see how well those data support its use.
- Potential Adverse Events: Contrary to popular belief, nutraceuticals can be dangerous; it’s essential to highlight this aspect.
- Personal Curiosity: My mild interest in launching a dietary supplement adds a personal touch to this response.
Step 1. Define the Question
Following my post titled “Mastering Standard Response Letters: A Tactical Breakdown of Medical Studies,” I will define the question. Our response should answer questions about the safety and efficacy of ashwagandha. We may have to narrow down the response based on what is available in the literature, but this is a good starting point. Another caveat is that with nutraceuticals, we must be careful with claims about treatment and efficacy from a regulatory perspective.
Step 2. Literature Search
Following my guide titled “It’s Time for a Medical Information Response Revolution,” the next step is a literature search. I need to select 3-5 key articles to summarize in my response. Searching “ashwagandha” and limiting to randomized controlled trials (RCTs) or meta-analyses, my search began with 44 results from PubMed. I find this to be a manageable number of references (anything under 50), so I skimmed the abstracts, cross-referenced the results with a Google search, and realized I needed to narrow the question defined in step 1 to “use for stress and anxiety.”
Step 3. Make a Quick Outline
After reviewing several articles on the use of ashwagandha for stress and anxiety, I created the following outline:
Ashwagandha Significantly Reduces Measures of Stress and Anxiety in Adults
- Chandrasekhar et al, 2012:
- Give a full summary
- Free full text (FFT)
- 64 patients
- 60 Days
- 300mg twice daily (BID)
- Outcomes: serum cortisol levels, PSS, GHQ28, DASS
- Akhgarjand et al, 2022:
- Brief summary
- Meta-analysis of 12 studies
- 1002 patients
- Outcome: pooled standardized mean difference.
Ashwagandha SR Capsules Improve Measures of Cognitive Functions and Stress Reduction in Adults Under Stress
- Gopukumar et al, 2021:
- Full summary
- 130 Patients
- 90 Days
- 300mg SR daily
- Outcomes: CANTAB, PSS10, cortisol level, OHQ score, PSQI, serum BDNF
Clinical Trials Show Reduced Anxiety and Positive Changes in Steroid Hormones in Adults With Stress and Anxiety Given Ashwagandha
- Lopresti et al, 2019:
- Full summary
- 60 Patients
- 60 Days
- 240 mg daily
- Outcomes: HAM-A, DASS-21, cortisol, DHEA-S, testosterone
- Langade et al., 2019:
- Brief summary
- 60 Patients
- 70 Days
- 300mg BID
- Outcomes: sleep scales, HAM-A
Ashwagandha Reduced Stress Markers and Supported Weight Management in Adults with Chronic Stress
- Choudhary et al, 2017:
- Full summary
- 52 Patients
- 56 Days
- 300 mg BID
- Outcomes: PSS, food cravings, OHQ, 3-factor eating, cortisol, weight, BMI.
Cite the remaining studies as “additional data”.
Step 4. Summarizing the Data
For the next step, I summarized the data following the guidance in my previous post titled, “Crafting a Standard Response Letter with Agility and Precision: Part 2 – Developing and Structuring Content“. Here are some key points to remember:
Key points for data summary:
- The summary bullet should be a brief, too long didn’t read (TLDR) summary that includes the most important study design elements followed by the conclusion or single key results.
- The section headers should be even more brief; think of headlines in a newspaper, but keep it balanced!
- The first sentence of the first paragraph should be a more detailed TLDR that includes key design information, objectives, and conclusions or key results.
- Each study summary should be 2-3 paragraphs max unless you are breaking up text that would have been 1 paragraph with graphic elements or bullet points.
- Use headings and subheadings as much as possible.
- Add a graphic element for at least the 2 main studies summarized.
- Refer to similar data as supporting info, don’t provide full summaries.
- Hyperlink the summary bullets to section headers.
- Hyperlink all references.
Pro tip: Hyperlinking may cut off the end of your reference when adding a hyperlink. Currently, the only workaround is to paste the full reference into the “text to display” field, then you have to go through and edit the reference and add formatting (eg, italics to the journal).
Step 5. Data Check and Edit
Data check and editorial review should be done by someone else, but since this was written as an example for my website, I reviewed the response myself.
As noted previously, since this is a supplement, it has some unique regulatory challenges. Therefore, I went through the response and removed the words treat, treatment, patient, and efficacy to ensure regulatory compliance in the US. Most of you won’t be creating standard responses for supplements, but reviewing responses from a regulatory perspective is always a good idea to ensure balance.
Another note on the example letter I drafted. The safety results were very favorable in all of the articles summarized. However, there is a pretty good safety study of ashwagandha. I did not include it because the study was on healthy individuals, not adults under stress. It is always a balance between giving information the requestor needs and providing only what was requested. As far as safety is concerned, providing more info is acceptable. But in this case, if this were a real standard response, important safety information (ISI) shared with the response would cover any information in that safety study. We aim to create more straightforward and concise standard response letters, so I left it out.
Step 6. Sharing
This is the step where you upload your final letter to be used in response to unsolicited requests for medical information—time to sit back, relax, and enjoy the fruits of your labor. For my purposes, I integrated this content into my website and shared it on social platforms. Take a look and see what you think.
Standard response letters are critical components of medical information in the pharmaceutical industry. It’s essential to approach them with agility, precision, and boutique craftsmanship. At CoreMed Communications LLC, we strive to excel in writing standard response letters that address unsolicited medical information requests with quality and speed. Crafting a response for ashwagandha allowed me to demonstrate a methodology that could be applied to a wide variety of substances.
I hope you enjoyed this step-by-step guide. I look forward to continuing to share insights that contribute to the evolution of our field.
For more insights and services, please visit CoreMed Communications LLC.