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The approval of medications is based on scientific studies of their efficacy. But how well a drug works is often measured by what degree you resemble the population used in the studies. Seat belts are not properly fitted for women because they were never used in safety testing. The same holds for medications where genetics and environmental factors may be critical but underappreciated variables. A new study looked at 24 new cardiovascular drugs approved by the FDA between 2006 and 2020. The researchers determined the number of Black versus Caucasian participants based on the racial prevalence of the disease being treated in the US. Simply put, if 40% of individuals with Disease X are Black, was the percentage of Blacks participating in the study more or less – how well aligned was the...

“Our findings from this large nationally representative sample of US adults show that frequent consumption of meals prepared away from home is significantly associated with increased risk of all-cause mortality.” 

Yang Du, MD, Ph.D. candidate, Department of Epidemiology, University of Iowa

How did Dr. Du and the rest of the team come to this conclusion? The study used data from NHANES, an ongoing cross-sectional study of Americans involving questionnaires and physical examinations. The data used in the research came from 35,000 respondents, age twenty or more, between 1999 and 2014, who reported dining out.

The responses to 

  • “On average, how...

My esteemed (1) colleague Dr. Alex Berazow recently wrote a fantastic article about how Johnson & Johnson was strong-armed by predatory lawyers who took advantage of some sketchy data and the scientific ignorance of pro-plaintiff leaning juries. Even the title is great: "Thank You, Trial Lawyers, For Protecting Us From The Scourge Of Baby Powder." 

Many species of sharks must keep swimming so they can breathe and it would seem that many species of trial lawyers, arguably a different species – but not by much – must keep suing so they can buy a 2021 Mercedes...

McKinsey & Company made use of data provided by Curriculum Associates, a company that devises curriculum and testing used by “30 percent of K–8 students across the US.” They did fall assessments of student knowledge, which reflected the remote learning from March to June, comparing similar evaluations made in the fall during 2017 to 2019. For those concerned about the “summer dropoff” in remembering, using data from each fall would compensate for that event. 

“…students in their sample learned only 67 percent of the math and 87...

Background

I suppose we can say that, like pornography, I can identify a processed food when I see it. And while that is reasonable for a casual conversation, when scientific studies are used in crafting public health regulation, we need to be sure we all agree on what “processed” means. A new study shows that for scientists, there is no clear definition.

“…the classification criteria used are ambiguous, inconsistent and often give less weight to existing scientific evidence on nutrition and food processing effects.”

We use classification schemes to identify foods that alter our health, for good or bad. The conventional system found on food labels...

It's been a tough time to be an anti-vaxxer, and it just got tougher. A letter to the editor in the New England Journal of Medicine revealed how effective the Pfizer–BioNTech and Moderna vaccines are at preventing infection among frontline health care workers (group 1a). How effective were the shots? Very. And these results provide real-world evidence that reinforces Phase 3 efficacy data. It is becoming increasingly difficult to argue that the mRNA vaccines have performed in any way other than spectacularly.  

William Daniel, M.D. and colleagues at the University of Texas Southwestern Medical Center reported on a vaccination program at their hospital that began on December 15, 2020 –...

Denmark does almost double the testing for COVID-19 than we do in the US, 10% versus about 6%. Using that database, researchers looked at the two waves of infections Denmark has experience – the first, from February to June, the second from September to December. In all, there were 3.96 million tests performed, more than two-thirds of their population was tested at least once, and 43% had more than one test. The first wave saw 2.2% of the roughly 533,000 people tested were COVID-19 positive; the second wave saw 4.3% infections among about 3.48 million individuals. 

How many individuals with an initial infection were reinfected?

  • Of the initial cohort that was positive, 0.6% were reinfected in the second wave
  • Your...

Obesity-related issues are more problematic than those associated with smoking, considering the tsunami of at least forty chronic preventable diseases, which result in its wake. My last three articles in this series discussed the basic physiology of this issue, illustrating why obesity is such a complex problem, not only to prevent in an industrialized culture, but far more so to resolve as well as discussed herehere, and here.

Where do we begin to resolve the...

Last year, I wrote an article about Antibe Therapeutics' potentially revolutionary drug (1), ATB-346 - a derivative of naproxen, shown in Phase 2 trials in Canada to reduce pain and inflammation, sparing the stomachs of the participants. The drug is now called otenaproxesul and the company got thumbs up from the FDA, which just approved its IND (investigational new drug) application.

An IND is the first of many hurdles that a potential drug must face on its way to the pharmacy (1). It gives the company permission to conduct first-in-man experiments.

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