The hottest FDA Substack posts right now

And their main takeaways
Category
Top Science Topics

AHM v. FDA reaches the Supreme Court

Adam's Legal Newsletter • 499 implied HN points • 28 Mar 24
🇺🇸 U.S. Politics Legal Supreme Court FDA Abortion Standing
  1. Plaintiffs in the case lack standing, which weakens their argument. They need to show personal harm, not just philosophical opposition.
  2. Even if plaintiffs had standing, their claims fail on the merits. The FDA's decisions were well-reasoned and based on evidence, debunking plaintiffs' objections.
  3. Banning mifepristone won't help the plaintiff-doctors study it; rather, it will hinder data collection. The FDA's evaluation of studies appears rational and reasonable.

Mifepristone and the rule of law, part II

Adam's Legal Newsletter • 2037 implied HN points • 10 Apr 23
🇺🇸 U.S. Politics Legal FDA Judicial Abortion Safety
  1. The district court's decision to overturn the FDA's approval of mifepristone is based on a variety of reasons, such as standing, timeliness, exhaustion, and the merits of the FDA's actions.
  2. The court assessed issues like the criteria for standing, timeliness of the lawsuit, the exhaustion of legal claims, and the agency's compliance with regulations.
  3. In examining the merits, the court questioned the FDA's safety analysis, imposition of restrictions, political influences, and the reasoning behind decisions made over a span of decades.
Get a weekly roundup of the best Substack posts, by hacker news affinity:

Mifepristone and the rule of law, part III

Adam's Legal Newsletter • 1377 implied HN points • 13 Apr 23
🇺🇸 U.S. Politics Legal Standing Abortion FDA
  1. The US Court of Appeals for the Fifth Circuit partially granted the FDA's motion regarding mifepristone, subjecting it to pre-2016 regulatory requirements.
  2. The Fifth Circuit's decision was criticized for its analysis of standing, with concerns raised about statistical certainty and the potential harm to doctors.
  3. The court's reasoning on timeliness and exhaustion was questioned, with issues seen as less relevant due to the stay on the 2000 approval of mifepristone. The argument that the FDA violated the Administrative Procedure Act was also discussed.

Robert Califf the FDA commissioner is making inappropriate and irresponsible claims about vaccines and boosters on twitter

Vinay Prasad's Observations and Thoughts • 176 implied HN points • 04 Jan 24
🏥 Health Politics FDA Vaccines Boosters Misinformation Twitter
  1. FDA commissioner Robert Califf is making inappropriate claims about vaccines and boosters on Twitter.
  2. Califf's claims are not supported by randomized trials, which go against FDA standards.
  3. Califf is spreading misinformation and using low quality evidence, acting more like a Pfizer spokesperson than a respected academic and scholar.

A Top FDA Official Makes Stunning Admission About Initial COVID Vaccine Approval

Unmasked • 102 implied HN points • 01 Mar 24
🏥 Health Politics Vaccines COVID FDA Pandemic
  1. COVID vaccines have faced challenges like waning protection, ineffective boosters, and increased side effect risks.
  2. The CDC approved multiple additional vaccine doses, bringing the total up to nine, but none guarantee protection against infection or transmission.
  3. Recent congressional testimony raised concerns about the early days of COVID vaccine approval.

ICAN Acquires Critical FDA Safety Reports Concerning COVID-19 Vaccines + VAERS URF computation

Steve Kirsch's newsletter • 13 implied HN points • 22 Jan 25
🏥 Health Politics Vaccines FDA Public Health
  1. The FDA's safety monitoring for COVID-19 vaccines is considered inadequate, as it hasn't identified any serious issues despite many reports of adverse events.
  2. A significant portion of reports in the VAERS system comes from COVID-19 vaccines, indicating potential underreporting in the system that needs addressing.
  3. There are serious concerns about the number of excess deaths related to COVID-19 vaccinations, with many not reported, raising alarms about the transparency of vaccine safety data.

Clinical Trial to License RotaTeq, Like Almost All Childhood Vaccines, Did Not Use a Placebo Control

Injecting Freedom • 80 implied HN points • 25 Jun 23
🏥 Health Politics Vaccines Clinical Trials FDA
  1. Most childhood vaccines were licensed without using a placebo control in their clinical trials.
  2. The clinical trial for RotaTeq did not use a true placebo as the control group, but included bioactive ingredients.
  3. Robert F. Kennedy, Jr. advocates for vaccine safety and freedom of choice without restricting access to vaccines.

I finally was able to talk to a top official at FDA media relations live. Here's what happened...

Steve Kirsch's newsletter • 12 implied HN points • 15 Mar 24
🏥 Health Politics FDA Vaccines Misinformation Dialogue Safety
  1. The individual made multiple attempts to contact the FDA regarding various concerns, but did not receive any response.
  2. Despite lack of response, the individual was able to connect with a live member of FDA media relations leadership and presented their offer for a public dialog to address differences.
  3. While unsure of FDA's willingness to engage in public discussion, the individual finds the connection made with FDA media relations leadership intriguing.

The Journal of the American Medical Association Finally Questions Whether the FDA Should be Approving Useless No-Evidence Cholesterol-Lowering Drugs

Harnessing the Power of Nutrients • 0 implied HN points • 21 Jan 10
🏥 Health & Wellness Medicine FDA Cholesterol Heart Disease Pharmaceuticals
  1. The evidence suggests that drugs lowering cholesterol may not actually prevent heart attacks by lowering cholesterol, but by clearing LDL from the bloodstream more quickly.
  2. The FDA approved cholesterol-lowering drugs based on their ability to lower cholesterol levels, without concrete evidence of preventing heart disease.
  3. Recent studies have suggested that some cholesterol-lowering drugs like ezetimibe may not effectively prevent heart disease, sparking questions about the approval process and physician prescribing practices.

Cholesterol Politics

Harnessing the Power of Nutrients • 0 implied HN points • 05 Feb 09
🏥 Health Politics Health Freedom Regulations Conflicts of Interest Pharmaceutical industry FDA
  1. The post discusses the war on cholesterol as a war on freedom, covering issues like the National Animal Identification System, Codex Alimentarius, and the Campaign Against Raw Milk.
  2. The site plans to address conflicts of interest, the pharmaceutical industry, and the FDA's revolving door, along with the Federal Reserve in the future.
  3. The focus is on exploring how various factors impact health freedom and choices.