Let me introduce myself. My name is Mark Sisson. I’m 63 years young. I live and work in Malibu, California. In a past life I was a professional marathoner and triathlete. Now my life goal is to help 100 million people get healthy. I started this blog in 2006 to empower people to take full responsibility for their own health and enjoyment of life by investigating, discussing, and critically rethinking everything we’ve assumed to be true about health and wellness...Tell Me More
Chimps hear music but they don’t hear it, man.
Heart disease patients who were intolerant to statins had more cardiovascular events than those taking statins, but they also lived longer.
The house mouse is at least 15,000 years old.
Daily tea may protect against cognitive decline.
Episode 162: Dave Asprey: Host Elle Russ chats with The Bulletproof Exec himself, Dave Asprey, about his new book, Head Strong, which helps people boost cognitive function, optimize brain health, and eliminate the dietary and environmental triggers bringing us down.
What’s unsafe for your pets to eat? Here’s the real list.
Genetic links between Indians and Latin Americans.
Suicide risk assessments might increase the risk of suicide.
Here’s what happened when three people measured their individual glucose responses to different foods.
McDonald’s switches to fresh beef in their quarter pounders.
Next time you’re in Istanbul, you may be able to work off some of that doner kebab by trampolining and rope-swining your way through a city park.
A descent into India’s strange, beautiful step-wells.
How shame retards personal development, plus other notes on mindfulness and self-judgment.
Prince George is attending a nursery school where having a best friend—an essential aspect of human development—is banned.
Patients are increasingly opting to stay awake during surgery.
True crime story I liked: How the Iceman was killed.
Study I found interesting: Physicians who spend more money on patient care do not produce better outcomes.
Article I’m pondering: Where Zika is most likely to hit the continental United States.
Product I want to try but probably shouldn’t: Black Insomnia Coffee, sporting the highest caffeine levels ever recorded.
Miscellaneous news I enjoyed: Dinosaur descendent attacks New Jersey family, plunging headfirst through the windshield.
One year ago (Apr 2– Apr 8)
“I have worked in pharmaceutical safety for six years, and am involved in clinical trials every day. The following is my personal opinion and does not necessarily reflect the opinion of my employer.
I’d just like to clarify the point about study discontinuation, since Mark points this out as a key smoking gun here. Many drugs are now tested for so called MACE (major adverse cardiac events) events – this is particularly true with diabetes drugs but is often seen with other classes including CV drugs. This really became more common after Avandia and the discovery of unintended CV events. Cardiovascular outcomes trials are almost always results-based and do not have well-defined timelines. That is, they go until they reach enough MACE events to draw statistical significance, then stop. Drug companies will have some idea of how long this should take, based on their knowledge of patients with this disease. Without seeing the protocol I don’t know about the timelines here, but I would expect that they reached their endpoints early. Clinical trials are massively expensive and companies aren’t going to keep running a trial once they get to a level where data is statistically significant.
Ending a study early doesn’t necessarily indicate poor outcomes related to study drug. It could mean that they have reached the designated number of endpoints in the control group. More importantly, it could actually indicate that their treatment is so effective that it’s unethical to keep giving patients a placebo or comparator. This happened with a cancer drug that I was working on – it was so clear that the drug was extending lives that FDA didn’t feel it was ethical to withhold the treatment from the other group. I doubt that’s what happened here, but it does happen and ending a study early isn’t damning on its own. In fact, Amgen is about to enroll on a long term, open label extension of this study to examine potential adverse events, so I highly doubt that this was stopped early due to safety concerns.
Otherwise, I agree with you that it didn’t improve mortality and therefore is not a huge deal. Wall Street also agreed, and Amgen stock took a hit, even with positive results.”
– Important insight from an insider. Thank, wildrover.