https://www.goodreads.com/review/show/8653916360 Straight into Darkness by Faye Kellerman Mike Guth‘s review Jun 02, 2026 · edit I have decided to write book reviews, when time allows, for the audiobooks to which I listen, because I pick up new friend requests on goodreads. Short synopsis: “Lustmord — the joy of murder. The terrifying concept seems apt for the brutal […]
Archive for the ‘Regulatory Medical Writing’ Category
Straight into Darkness: Book review by Michael A. S. Guth
Posted by Michael A. S. Guth on June 11th, 2026
𝐂𝐚𝐧 𝐭𝐡𝐞 𝐔𝐒 𝐁𝐞𝐜𝐨𝐦𝐞 𝐚 𝐓𝐡𝐢𝐫𝐝 𝐖𝐨𝐫𝐥𝐝 𝐂𝐨𝐮𝐧𝐭𝐫𝐲? 𝐓𝐡𝐞 𝐃𝐫𝐢𝐩, 𝐃𝐫𝐢𝐩, 𝐃𝐫𝐢𝐩 𝐨𝐟 𝐃𝐞𝐜𝐥𝐢𝐧𝐢𝐧𝐠 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐂𝐨𝐯𝐞𝐫𝐚𝐠𝐞.
Posted by Michael A. S. Guth on June 11th, 2026
Health insurance coverage in the USA is declining, driven by the expiration of enhanced Affordable Care Act (ACA) subsidies and post-pandemic Medicaid unwinding. Millions are dropping out of the market due to unaffordable premiums, while those who retain plans face narrower networks, stricter coverage denials, and higher out-of-pocket costs. The decline in US health insurance […]
𝐖𝐡𝐚𝐭 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐦𝐨𝐬𝐭 𝐡𝐚𝐫𝐦𝐟𝐮𝐥 𝐟𝐨𝐨𝐝 𝐢𝐧𝐠𝐫𝐞𝐝𝐢𝐞𝐧𝐭𝐬 𝐭𝐡𝐚𝐭 𝐜𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐞 𝐭𝐨 𝐝𝐞𝐦𝐞𝐧𝐭𝐢𝐚 𝐫𝐢𝐬𝐤?
Posted by Michael A. S. Guth on June 10th, 2026
The most harmful industrial ingredients contributing to dementia risk are processed meat preservatives (nitrites/nitrates), added sugars (high-fructose corn syrup), and chemical additives like emulsifiers. Rather than focusing on a single nutrient, public health studies—including recent 2026 data from the Harvard T.H. Chan School of Public Health—point to specific chemical formulations and industrial ingredients that directly […]
Demystifying Long-Horizon Survival Forecasting in Oncology HTA—Perspective Manuscript
Posted by Michael A. S. Guth on June 9th, 2026
Dear Drs. xxxxxxxxxxxx and xxxxxxxxxxxxxxx, I write to inquire whether the Journal of Clinical Epidemiology would consider a Perspective manuscript entitled xxxxxxxxxxxxxxxxxxxxxxxx. The manuscript (~5,100 words, 37 references) addresses a problem that experienced clinical epidemiologists and HTA reviewers recognize but that the published literature has been reluctant to name directly: when Phase 3 trials produce […]
Adeno-associated virus serotype 9 (AAV9): tool of gene therapy that crosses the BBB
Posted by Michael A. S. Guth on June 4th, 2026
Adeno-associated virus serotype 9 (AAV9) is highly valued in gene therapy because it can cross the blood-brain barrier. It is primarily used to treat monogenic neurological and neuromuscular disorders, most notably Spinal Muscular Atrophy (SMA). AAV9 vectors deliver functional genetic material to replace or suppress faulty genes. Approved treatments and advanced clinical trials using AAV9 […]
HEOR Survival Statistics and Data Shading
Posted by Michael A. S. Guth on June 4th, 2026
𝐖𝐡𝐞𝐧 𝐚 𝐝𝐫𝐮𝐠 𝐬𝐡𝐨𝐰𝐬 𝐚 𝐡𝐚𝐳𝐚𝐫𝐝 𝐫𝐚𝐭𝐢𝐨 𝐨𝐟 𝟎.𝟖𝟎 — 𝐰𝐡𝐢𝐜𝐡 𝐬𝐨𝐮𝐧𝐝𝐬 𝐢𝐦𝐩𝐫𝐞𝐬𝐬𝐢𝐯𝐞 — 𝐚𝐧𝐝 𝐭𝐡𝐞 𝐭𝐫𝐢𝐚𝐥 𝐦𝐞𝐝𝐢𝐚𝐧 𝐬𝐮𝐫𝐯𝐢𝐯𝐚𝐥 𝐰𝐚𝐬 𝟏𝟓 𝐦𝐨𝐧𝐭𝐡𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐧𝐭𝐫𝐨𝐥 𝐚𝐫𝐦, 𝐭𝐡𝐞 𝐦𝐚𝐭𝐡 𝐰𝐨𝐫𝐤𝐬 𝐨𝐮𝐭 𝐭𝐨 𝐫𝐨𝐮𝐠𝐡𝐥𝐲 𝟑 𝐚𝐝𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐦𝐨𝐧𝐭𝐡𝐬 𝐚𝐭 𝐭𝐡𝐞 𝐦𝐞𝐝𝐢𝐚𝐧. 𝐍𝐨𝐭 𝐲𝐞𝐚𝐫𝐬. 𝐌𝐨𝐧𝐭𝐡𝐬. 𝐒𝐨𝐦𝐞𝐭𝐢𝐦𝐞𝐬 𝐰𝐞𝐞𝐤𝐬. The drug costs $28,000/month. If a cancer drug showed “statistically significant survival […]
𝐒𝐮𝐩𝐩𝐥𝐞𝐦𝐞𝐧𝐭 𝐌𝐲𝐭𝐡𝐬: 𝐓𝐡𝐞 𝐓𝐫𝐮𝐭𝐡 𝐀𝐛𝐨𝐮𝐭 𝐍𝐢𝐚𝐜𝐢𝐧𝐚𝐦𝐢𝐝𝐞 𝐚𝐧𝐝 𝐒𝐤𝐢𝐧 𝐏𝐫𝐨𝐭𝐞𝐜𝐭𝐢𝐨𝐧
Posted by Michael A. S. Guth on May 17th, 2026
Niacinamide is currently one of the most celebrated ingredients in skincare, praised in every beauty and wellness journal for its ability to strengthen the skin barrier topically. But lately, there has been a lot of buzz about taking it orally to prevent skin cancer. Does the science back up the hype? Yes—but with some major […]
Posted in Regulatory Medical Writing 
Comments Off on 𝐒𝐮𝐩𝐩𝐥𝐞𝐦𝐞𝐧𝐭 𝐌𝐲𝐭𝐡𝐬: 𝐓𝐡𝐞 𝐓𝐫𝐮𝐭𝐡 𝐀𝐛𝐨𝐮𝐭 𝐍𝐢𝐚𝐜𝐢𝐧𝐚𝐦𝐢𝐝𝐞 𝐚𝐧𝐝 𝐒𝐤𝐢𝐧 𝐏𝐫𝐨𝐭𝐞𝐜𝐭𝐢𝐨𝐧Real-World Evidence vs. Meta-Analyses: The Evolving Debate on Nicotinamide for Skin Cancer Chemoprevention
Posted by Michael A. S. Guth on May 17th, 2026
Real-World Evidence vs. Meta-Analyses: The Evolving Debate on Nicotinamide for Skin Cancer Chemoprevention The clinical utility of oral nicotinamide (NAM) for non-melanoma skin cancer (NMSC) chemoprevention remains a prime example of the tension between landmark RCT data, real-world evidence (RWE), and systematic evidence syntheses. While the 2015 Phase 3 ONTRAC trial established a 23% reduction […]
Posted in Regulatory Medical Writing Comments Off on Real-World Evidence vs. Meta-Analyses: The Evolving Debate on Nicotinamide for Skin Cancer Chemoprevention𝗙𝗿𝗼𝗺 𝗢𝗯𝘀𝗲𝗿𝘃𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗖𝗼𝗻𝘁𝗿𝗼𝗹: 𝗧𝗵𝗲 𝗡𝗲𝘄 𝗘𝗿𝗮 𝗼𝗳 𝗖𝗼𝗺𝗽𝘂𝘁𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗡𝗲𝘂𝗿𝗼𝘀𝗰𝗶𝗲𝗻𝗰𝗲.
Posted by Michael A. S. Guth on May 7th, 2026
𝗪𝗵𝘆 𝘁𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗗𝗲𝗽𝗲𝗻𝗱𝘀 𝗼𝗻 𝗕𝗿𝗶𝗱𝗴𝗶𝗻𝗴 “𝗪𝗲𝘁𝘄𝗮𝗿𝗲” 𝗮𝗻𝗱 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲.𝗧𝗵𝗲 𝗡𝗲𝘅𝘁 𝗟𝗲𝗮𝗽 𝗶𝗻 𝗔𝗜: 𝗚𝗿𝗼𝘂𝗻𝗱𝗶𝗻𝗴 𝗠𝗮𝗰𝗵𝗶𝗻𝗲 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗶𝗻 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗣𝗵𝘆𝘀𝗶𝗰𝘀. 𝗙𝗿𝗼𝗺 𝗢𝗯𝘀𝗲𝗿𝘃𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗖𝗼𝗻𝘁𝗿𝗼𝗹: 𝗧𝗵𝗲 𝗡𝗲𝘄 𝗘𝗿𝗮 𝗼𝗳 𝗖𝗼𝗺𝗽𝘂𝘁𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗡𝗲𝘂𝗿𝗼𝘀𝗰𝗶𝗲𝗻𝗰𝗲. The future of AI and biotech isn’t just about collecting more data; it’s about building better models of the underlying “physics” of the system. […]
Posted in Regulatory Medical Writing Comments Off on 𝗙𝗿𝗼𝗺 𝗢𝗯𝘀𝗲𝗿𝘃𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗖𝗼𝗻𝘁𝗿𝗼𝗹: 𝗧𝗵𝗲 𝗡𝗲𝘄 𝗘𝗿𝗮 𝗼𝗳 𝗖𝗼𝗺𝗽𝘂𝘁𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗡𝗲𝘂𝗿𝗼𝘀𝗰𝗶𝗲𝗻𝗰𝗲.𝗧𝗵𝗲 𝗠𝗮𝘁𝗵𝗲𝗺𝗮𝘁𝗶𝗰𝗮𝗹 𝗔𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗼𝗳 𝗡𝗲𝘂𝗿𝗼𝗽𝗹𝗮𝘀𝘁𝗶𝗰𝗶𝘁𝘆: 𝗜𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗻𝗴 𝗗𝗘 𝗠𝗼𝗱𝗲𝗹𝘀 𝘄𝗶𝘁𝗵 𝗠𝗼𝗱𝗲𝗿𝗻 𝗠𝗟
Posted by Michael A. S. Guth on May 7th, 2026
𝗧𝗵𝗲 𝗠𝗮𝘁𝗵𝗲𝗺𝗮𝘁𝗶𝗰𝗮𝗹 𝗔𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗼𝗳 𝗡𝗲𝘂𝗿𝗼𝗽𝗹𝗮𝘀𝘁𝗶𝗰𝗶𝘁𝘆: 𝗜𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗻𝗴 𝗗𝗘 𝗠𝗼𝗱𝗲𝗹𝘀 𝘄𝗶𝘁𝗵 𝗠𝗼𝗱𝗲𝗿𝗻 𝗠𝗟. 𝗕𝗲𝘆𝗼𝗻𝗱 𝘁𝗵𝗲 𝗦𝗶𝗻𝗴𝗹𝗲 𝗡𝗲𝘂𝗿𝗼𝗻: 𝗔 𝗨𝗻𝗶𝗳𝗶𝗲𝗱 𝗛𝗶𝗲𝗿𝗮𝗿𝗰𝗵𝘆 𝗳𝗼𝗿 𝗠𝘂𝗹𝘁𝗶𝘀𝗰𝗮𝗹𝗲 𝗡𝗲𝘂𝗿𝗮𝗹 𝗠𝗼𝗱𝗲𝗹𝗶𝗻𝗴. 𝗕𝗿𝗶𝗱𝗴𝗶𝗻𝗴 𝘁𝗵𝗲 𝗚𝗮𝗽: 𝗙𝗿𝗼𝗺 𝗗𝗲𝘁𝗲𝗿𝗺𝗶𝗻𝗶𝘀𝘁𝗶𝗰 𝗢𝗗𝗘𝘀 𝘁𝗼 𝗦𝘁𝗼𝗰𝗵𝗮𝘀𝘁𝗶𝗰 𝗣𝗼𝗽𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗗𝘆𝗻𝗮𝗺𝗶𝗰𝘀. Large neuronal networks exhibit complex dynamics across multiple scales, from single-neuron excitability to whole-brain rhythms. At the Institute, we are examining how a unified […]
Posted in Regulatory Medical Writing Comments Off on 𝗧𝗵𝗲 𝗠𝗮𝘁𝗵𝗲𝗺𝗮𝘁𝗶𝗰𝗮𝗹 𝗔𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗼𝗳 𝗡𝗲𝘂𝗿𝗼𝗽𝗹𝗮𝘀𝘁𝗶𝗰𝗶𝘁𝘆: 𝗜𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗻𝗴 𝗗𝗘 𝗠𝗼𝗱𝗲𝗹𝘀 𝘄𝗶𝘁𝗵 𝗠𝗼𝗱𝗲𝗿𝗻 𝗠𝗟