Bonkers new study ignores critical effects on cardiovascular health
It’s official: The medical mainstream has finally lost whatever was left of its collective mind.
It’s pushing a new cholesterol drug through the approvals process as fast as it can, vowing that THIS ONE is going to be BETTER than all the rest.
And sure, some of the numbers look impressive... if you believe in the tired old myth that lower cholesterol is always better. (Spoiler alert: It’s not.)
This new drug is a mix of bempedoic acid and the old cholesterol med Zetia -- and in a new study, the combo cut LDL levels by a whopping 35 percent in supposedly “high-risk” patients.
That’s far better than either drug alone… and more than 10 times the effect of a placebo.
The results are so “stunning” that stock shares in the company that makes it jumped as experts claimed that this med could submitted for FDA approval in just a few months.
Notice what’s missing in the rush to bring this drug to the market as quickly as possible?
Not a peep about actual clinical outcomes.
No word on who had or avoided cardiovascular disease. Nothing on whether this new drug and its super low cholesterol levels cut the risk of heart attack or stroke.
And of course, no mention of whether the drug saved, extended, or even improved lives.
Why? Because researchers DIDN’T study it!
Yes, that’s right. The main clinical outcomes that patients care about – and the only standards by which a drug like this should be approved – weren’t part of the study.
There’s a major study out next year that many believe will be the ultimate difference-maker when it comes to approval.
Think that one will have those elusive outcomes?
It’s a safety study, since there are concerns over liver issues. In fact, we won’t get data on outcomes until a study that’s due out in 2022.
The FDA could approve the drug “conditionally” right now, as it often does. That’s its way of saying, “Hey, let’s approve it and get it out there and look again later.”
“Later,” as in AFTER that new study is published in 2022.
Until then, the drug would go on the market and be pushed on patients across the country… and no one will know for sure if it’s actually helping anyone.
Yes, approve first. Check the results later.
How insane is that?
So, watch out for this one… and while you’re at it, watch out for any doc who obsesses over LDL numbers alone.
Other factors including particle size and oxidation are far more important -- and both can be treated with natural antioxidant therapies instead of questionable meds.