On July 24th, 2014 the [FDA approved Praluent] to treat certain patients with high cholesterol. This is the first drug in the new class of so called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. They basically block the uptake of LDL into cells and have demonstrated LDL drops of upwards of 60% in patients. But I have serious concerns about these drugs. They were approved based on very flimsy evidence. There were only 5 trials looking at the efficacy and safety of Praluent involving 2,476 participants. And they only demonstrated that the drug lowers LDL, nothing was demonstrated in terms of outcomes. That is bad, bad, bad. And then it really hits the fan. Guess how much this will cost. That’s right, [$14,600/year]. Let me repeat that, $14,600/year.
And there is lots of suspicion that these PCSK9 drugs may actually end up being very dangerous and have really bad side effects. There have been really [harsh discussions] within the medical community about the rush to approve the PCSK9 drugs pointing to previous debacles. [Dr. Malcolm Kendrick] speculates that the PCSK9 may also cause patients to become diabetic, not with some mild rate as has been seen in statins but that they will cause a second epidemic wave of diabetes among PCSK9 patients.
I saw the booth at the ADA Scientific Session but didn’t pay much attention. But later as I read more I became more and more concerned. As a patient, I worry that the system has become corrupt. Medications that are profit opportunities are rushed to marked without proper study. The PCSK9 drugs were studied on certain high risk patients but these drugs will likely be widely prescribed for populations that were never part of the original studies. Why would the FDA rush to approve this drug. Who knows what kind of harm will happen. I absolutely won’t accept this drug, even in free samples until I see real evidence that it won’t harm or kill me while stealing all the money out of my pocket.