Do you want to hear a real horror story for Halloween eve?
A new study says it’s the “first ever” to show that statin drug therapy lowers the risk of heart disease among people with elevated cholesterol (above 190 mg/dL) and no prior history of heart disease. It claims to show the drug supports “primary prevention” of heart disease.
That’s quite a remarkable statement — if it’s true. Not so much because they present “never-before-seen” evidence, but because it confirms that all previous studies have not shown that statin drugs support the primary prevention of heart disease.
Of course, the FDA approved statin drugs because they lower cholesterol. But drug companies could never provide any evidence that the drugs actually reduce heart disease.
So, given the lack of any evidence (apparently until now), why have statin drugs been doled out like candy to supposedly prevent heart disease for the past quarter-century?
This new clinical trial followed 2,500 men without pre-existing cardiovascular disease. It seems like a big number…but given the millions of men taking this drug, surely the study could have been larger.
In fact, one of the many negative studies on statins included essentially the entire population of Sweden (about eight million people). But it failed to show any benefits for the drugs. So — big pharma doesn’t like to talk about that one…
But now, suddenly, a modest study with questionable control on just 2,500 men is supposed to rewrite history? (The new study is indeed modest in all ways except the authors’ outlandish claims.)
Plus, the new study performed a post-hoc analysis. “Post –hoc” is a Latin word, meaning “after this.” Post-hoc analysis involves observing data after a study has concluded to find patterns that weren’t initially primary objectives. It’s essentially additional, unplanned analysis of hypotheses and variables not originally determined before the start of the experiment.
I believe the best kind of evidence comes from prospective studies with adequate controls set in place to determine all data at the start of the study. Then, researchers follow participants to thoroughly observe new outcomes as they arise…not after the fact.
But apparently, the authors have an explanation for their poor design.
They now claim they could never perform a higher-quality, prospective study with placebo control. They say it would be “unethical” to have a placebo group. It would “deprive” the participants of statins and the drugs’ new-found benefits.
But since this is the first and only study to actually find any benefits for statins, why not look at the preponderance of evidence from all the prior studies that failed to show benefits? Now it’s suddenly “unethical” to do the kind of research that could actually settle the question?!
These kinds of clowns know how to mouth the word “ethics.” But they put it in their back pockets after consulting with a clinically clueless, newly minted Ph.D. “medical ethicist.” (I will tell you about what else they put in their back pockets in a moment.)
Finally, if these researchers could find their way out of the cardiology clinic, they would find growing numbers of patients who refuse to take statins. They would also find increasing numbers of gerontology and primary care physicians who refuse to prescribe them.
So, they should have no trouble finding plenty of patients to observe in a prospective study who don’t mind being “deprived” of statins (and in fact, would prefer it)!
The whole argument is hollow…
Men and women respond differently to drugs
Ultimately, the researchers conclude that their analysis provides “novel” supporting evidence to “reinforce” current recommendations for all men and women with elevated cholesterol to take a statin drug.
That’s quite a broad statement…especially given the limitations of the study’s design and the fact that it only included men. As any qualified medical researcher knows, men and women respond very differently to drugs. So — I would never recommend women take a drug based on the results of a small, isolated study that only included men.
But brace yourself, because it gets even worse…
Next, the researchers said we should prescribe the drugs to all men and women with high cholesterol, “without the need for risk estimation.” In other words, they said we don’t need to worry about whether or not statins are actually safe.
Oh, thank goodness! We can now put a stop to all the detailed, multi-million dollar analyses that have been done by National Institutes of Health (NIH) and other academic organizations that try to scientifically assess risk. Instead, just give out the drugs to everyone. How convenient! (Hopefully, you get the sarcasm.)
Additionally, I didn’t see anything in the summary or conclusions of the new study regarding all the negative side effects that so many other studies have found. Nothing took away from their blanket endorsement to blindly dole out these drugs.
As a Medical Examiner, I was trained to follow the preponderance of evidence. In other words, if a few dozen studies were negative and just one study was positive, I would ask one common sense question: Why were all the other studies negative and suddenly just one study positive after all these years?
So, I find myself asking that question again here. And if I were one of these researchers, I’d certainly need more answers before setting in stone clinical practices that affect millions of people.
Indeed, this is a prime example where I would say, “more research is needed,” before closing the books on the question, as these researchers suggest we do.
We are trained like law enforcement to be very skeptical and inquisitive. So — here is the real evidence that best explains this study to me…
At the very end of the study, near page 60, we learn about the hands that rock this cradle. Over 25 drug companies supported the study…and the authors personally.
Don’t put an ounce of faith in this new study and keep far away from statin drugs.
Instead, if you want to find the natural, heart-healing pathway to low blood pressure, a stroke-free brain… and never taking a dangerous heart drug again, check out my newly released Heart Attack Prevention & Repair Protocol. Click here to learn more or to enroll today.
“LDL-Cholesterol Lowering for the Primary Prevention of Cardiovascular Disease Among Men with Primary Elevations of LDL-Cholesterol Levels of 190 mg/dL or Above: Analyses from the WOSCOPS 5-year Randomized Trial and 20-year Observational Follow-Up,” Circulation. 2017 Sep 6; 136 (15)