They’re being called the next billion-dollar cholesterol meds. And they could be just months from showing up at doctors’ offices and pharmacies near you.
But when injectable PCSK9 blockers hit the market, they could end up robbing millions of their most treasured possession.
The clinical trials for these frightening new drugs proved that patients were paying a terrible price for lowering their cholesterol. A price that included delirium… dementia… and maybe losing forever the ability to recognize the faces of their kids and grandkids.
A key FDA panel recently had a chance to put a stop to PCSK9 blockers. But instead they chose to make countless Americans lab rats in a two-year genetic experiment.
One that could leave your brain in tatters.
Statins on steroids
PCSK9 blockers are being called statins on steroids – but the way they work may be more dangerous than any cholesterol med Big Pharma has ever developed.
The drugs are injected into your bloodstream and actually interfere with a key gene that’s responsible for regulating cholesterol in your body.
And if letting the drug companies play nutty professor with your DNA sounds worrisome enough, you haven’t heard the half of it. These meds are promising to drop your cholesterol to levels that are unheard of – and that may be incredibly hazardous.
Cholesterol levels that are too low are bad for your heart and can wreak havoc on your brain. And in the clinical trials for PCSK9 blockers – including Repatha by Amgen and Praluent, made by Sanofi and Regeneron – the damage to patients’ brains was already becoming apparent.
Researchers from Johns Hopkins crunched the clinical data and found that in one trial, patients were three times as likely to suffer serious cognitive problems – and in another, they were more than twice as likely. The problems included delirium, amnesia, difficulty in thinking and reasoning, and even dementia.
That was after a follow-up period of just several months. But keep in mind that the drug companies want you staying on these meds for years. Maybe even the rest of your life.
The brain problems suffered by people on PCSK9 blockers were so alarming that last year the FDA did something shockingly out of character. It actually sent a letter to the companies developing the drugs warning them of “neurocognitive adverse events.”
But instead of demanding a halt to the trials – or keeping PCSK9 blockers out of the market – the FDA did something that, unfortunately, is not out of character at all. An advisory panel recently gave Repatha and Praluent the green light while allowing the drug companies two full years to conduct follow-up studies on whether the meds harm your brain.
Or whether they can even reduce heart attacks and strokes, for that matter.
Patients will be given memory tests during these follow-up trials, but the researchers from Johns Hopkins are already raising concerns about how objectively those results will be reported.
We won’t know until 2017 the full risks of PCSK9 blockers. But the FDA will have the opportunity to approve the drugs as soon as later this summer — and it’s almost certain that they will.
When these drugs hit the market and we’re flooded with round-the-clock commercials, remember the names Repatha and Praluent and stay as far away as possible.
Because you know that no risk to your brain is acceptable. And Big Pharma and the FDA should have known that, too.
“FDA advisory panel recommends approval of alirocumab, citing value for patients with FH” Deborah Brauser, June 9, 2015, Medscape, medscape.com
“Early evidence linking PCSK9 inhibitors to neurocognitive adverse events: Does correlation imply causation? Expert analysis” Kristopher Swiger, MD, Seth Shay Martin, MD, MHS, Junt 1, 2015, American College of Cardiology, acc.org
“Approve PCSK9 inhibitor Evolocumab, FDA panel recommends, Michael O’Riordan, June 10, 2015, Medscape, medscape.com