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.
“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.
Mark Sisson is the founder of Mark’s Daily Apple, godfather to the Primal food and lifestyle movement, and the New York Times bestselling author of The Keto Reset Diet. His latest book is Keto for Life, where he discusses how he combines the keto diet with a Primal lifestyle for optimal health and longevity. Mark is the author of numerous other books as well, including The Primal Blueprint, which was credited with turbocharging the growth of the primal/paleo movement back in 2009. After spending three decades researching and educating folks on why food is the key component to achieving and maintaining optimal wellness, Mark launched Primal Kitchen, a real-food company that creates Primal/paleo, keto, and Whole30-friendly kitchen staples.