Beware the PSCK9 Drugs

On July 24th, 2014 the [FDA approved Praluent][1] 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][2]. 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][3] within the medical community about the rush to approve the PCSK9 drugs pointing to previous debacles. [Dr. Malcolm Kendrick][4] 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.
[1]: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455883.htm
[2]: http://www.pharmtech.com/fda-approves-praluent-first-pcsk9-inhibitor-us-0
[3]: http://www.medscape.com/viewarticle/841506
[4]: http://drmalcolmkendrick.org/2015/07/28/a-tale-of-mice-and-men/

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Doctor was telling me about this group of drugs in the pipeline for cholesterol as I have pretty much tried and said no to all of the common treatments because of different side effects. Have been hovering just over 200 total taking nothing, walking between 3-5 miles a day and same diet I have had all my life which is by no means hi or low cholesterol. Not going to jump into this trial group until they get some real world data, thanks for heads up Brian.

I’m pretty sure no one has shown long term improvement in cardiovascular outcomes with this class of drugs, either.

The statins apparently are helpful for some people vs. heart disease because they are anti-inflammatory and inflammation plays a huge part in heart disease. This new class, not so clear.