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PCSK9 solves the big statin problem (for Big Pharma™ anyway)
Member Forum >> Coronary Disease & Cholesterol Protocol >> PCSK9 solves the big statin problem (for Big Pharma™ anyway)

Bob Niland

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Posted: 6/6/2015 11:48:14 AM
Edited: 6/6/2015 12:52:42 PM (1)
 
MPT: FDA Staff Give PCSK9 Inhibitor Passing Grade
note: "passing", not Summa Cum Laude

It's not often that MPT warns us about big pharma progress, and so concisely. But one has to know how to read med press babble.

Statins have represented the first-line of treatment for patients with high cholesterol since the late 1980s, but many patients cannot manage their side-effects.

Funny, normally in consensus med publications, there's no routine mention of statin side effects at all, much less that they are so widespread that a new class of toxins is needed. It's usually statins-for-all, with no caveats whatsoever.

This new generation of injectable biologics, called PCSK9 inhibitors, could offer an alternative for statin-intolerant patients.

The real crisis that these new potions address is that all the statins are either off-patent, or will soon be. Prices are in free fall. The parachutes (patent extension gaming) are worn out. New balloons are desperately needed.

Briefing documents were released Friday on alirocumab, in which FDA staff were generally satisfied with the drug's efficacy and safety.

I translate “generally satisfied” as:
- the correct palms have been greased
- all revolving doors have been oiled
- career path promises are in place
- previous moles at the FDA are performing as expected
- everyone has confidence that the scam won't be exposed

Reducing circulating LDL cholesterol is presumed to mean fewer clogged arteries and fewer heart attacks. This "LDL hypothesis" represents the primary strategy behind past statin approvals, and a controversial one.

This is shaping up as the next generation of great cholesterol con.

As James Smith, MD, MS, director of the Division of Metabolism and Endocrinology Products, stressed in a memo, LDL is a surrogate endpoint, "not a clinical outcome that reflects how patients feel, function, or survive."

That's actually a surprising quote for MPT.

Alirocumab is a product of the French firm Sanofi and Tarrytown, N.Y.-based Regeneron. The application states that the drug would be for use in conjunction with a healthy diet …

As if they have the least clue what a healthy diet is.

... "for long-term treatment of adult patients with primary hypercholesterolemia (nonfamilial and heterozygous familial) or mixed dyslipidemia" …

I'm open to the possibility that PCSK9s might have some all-cause mortality benefit in specific genotypes and phenotypes, but we all know that's not the only demographic to whom this stuff will be promoted. Heck, almost no one knows what lipoprotein-implicated polymorphisms they carry.

Interestingly, one can find articles that claim that that PCSK9 is associated with a reduction in all-cause mortality, but no mention of that was made in this article, and the articles I looked at were pretty weasel-worded (“appear to”, “meta-analysis”, "preliminary information on clinical outcomes"), but I'm sure the New York Times will fall for it anyway (and conveniently run full pages ads for this stuff in the same edition).

... and patients with type 2 diabetes, …

Which is a totally optional ailment – trivially avoided with diet, and fully reversible with diet (to the extent that any complications are) and, even when advanced, most effectively treated primarily with diet. These people are dangerous.

… according to the FDA's hearing announcement. The target population includes statin-intolerant patients or those "for whom a statin is not considered clinically appropriate."

Are we only now hearing of this significant market segment? Why would that be?

Alirocumab's efficacy was studied in 10 multicenter phase III trials ... All 10 trials used percent change in LDL-cholesterol from baseline to week 24 as their primary endpoint.

Why not study outcomes rather than antiquated mythical metrics that may not matter?

"There were no marked disparities in deaths, serious adverse events (SAEs), or adverse events leading to discontinuation," noted the documents.

Notice what's missing here: one might expect a marked beneficial disparity in adverse events, or perhaps that they even had to discontinue the trial because events and deaths in the treated subjects ceased – apparently not. Translates to: we can sell this – it doesn't kill more than doing nothing.

As with any biologic, the emergence of anti-drug antibodies (ADA) is a concern.

This is window-dressing - mere simulation of concern for actual patient outcomes.

The committee hearing will focus on one central question: "For what population(s), if any, does the LDL-C-lowering benefit of alirocumab exceed its risks to support approval?"

As long as they consider the useless LDL-C as a meaningful marker for anything, parsing populations is pointless.

Beyond safety and efficacy one looming concern is the cost of these new biologic agents. The annual cost for PCSK9 inhibitors has been estimated at $7,000 to $12,000, …

Umm, that's the real point of these patented potions, folks. It's not an accidental and unfortunate side effect.

… no generic will be available for a decade or more, …

And with that, Big Pharma™ is warming up to score a bases-loaded home run.
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