At first, the FDA said that the shiny new cholesterol drugs Repatha and Praluent would be reserved for people with HeFH, an inherited disease that causes super-high cholesterol numbers.
Then we heard that these risky meds could also be prescribed for another limited group: folks who had tried everything but just couldn’t get their LDL down.
But doesn’t it seem rather odd that those Repatha commercials started running every day? Why would Amgen spend so much advertising money to promote a drug that should have had a limited market?
That’s because once drugmakers get their foot in the door, you can forget what they told the FDA.
It’s of utmost importance that you know this — because the danger in lowering cholesterol to the kinds of numbers that these drugs can accomplish is a signed, sealed, and delivered invitation to disaster.
‘Little clinical factors’
You’ve probably read a lot about Repatha and Praluent (also known as PCSK9 inhibitors) right here in eAlert over the past two years. And there’s a very good reason for that.
These drugs are extremely dangerous — even when they do exactly what they’re intended to, which is knock down LDL cholesterol (called the “bad” kind) to bargain basement numbers in the 20s and 30s, and maybe even lower!
But the potential risks of falling that low sound like a laundry list of the worst of the worst, ranging from depression and anxiety to cancer and hemorrhagic stroke.
And as we’ve been telling you from the very beginning, one of the biggest dangers in dropping cholesterol numbers to such low, uncharted territory has to do with your brain. Even before these meds ever hit the market, the FDA warned drugmakers about their potential danger of causing “neurocognitive adverse events,” a.k.a. dementia.
In fact, back when the first PCSK9 drug was approved, numerous experts spoke up about the need for ongoing, long-term trials to try to find an answer to the question of how they affect the brain.
That, however, is something neither Big Pharma nor its friends at the FDA seem at all concerned about.
In fact, a new study, paid for by Repatha’s maker Amgen, is aimed at finding out just why more prescriptions for this pricey med aren’t being OK’d.
In it, lead author Dr. Ann Marie Navar, a professor of cardiology at Duke Clinical Research Institute, moans and groans over the fact that so many patients are being kept from using Repatha because they’ve been denied payment by their insurance companies.
Well, it’s no wonder — this drug runs around $14K a year!
She was “surprised” at how “little clinical factors,” such as your actual cholesterol numbers, played into whether you would be denied coverage or not.
Really, Dr. Navar? That “little” factor was the very basis of approval for this drug. It matters a whole lot.
It’s bad enough that these PCSK9 inhibitors were approved for anyone. Now, they want everyone taking them!
If you’ve recently had that “cholesterol” talk with your doctor, you might have come away with the idea that this is some kind of golf score we’re talking about here — the lower the better.
But where cholesterol is concerned, that’s definitely not the case.
Even the most mainstream of medical centers, the Mayo Clinic, warns about “very low” LDL, though how low is too low, they’ve said, hasn’t been “defined” yet.
Maybe it falls below 40… but it could be higher. Who knows?
But don’t take any chances when it comes to the question of “How low can you go?” Because unless you’re careful, you could become part of the latest gamble with your health — the PCSK9 experiment.
Hopefully insurance companies will keep refusing to pay for these drugs, but even if they don’t, you always have your own personal right of refusal!
“Many patients denied costly new cholesterol drugs” Randy Dotinga, September 28, 2017, HealthDay, consumer.healthday.com