How To Save Zero Lives For The Low, Low Cost Of Two Million Dollars And Change

In our previous episode, we saw that statins – in addition to a number of other horrors – may be triggering ALS (commonly known as Lou Gehrig’s disease) in a small percentage of people taking them. Yes, the data came from an observational study, but the risk ratios are as high as those that tied lung cancer to smoking. We’re talking about people on some statins being more than 20 times as likely to develop ALS than people not on statins.

But what if risking ALS, cognitive decline, liver damage, diabetes, joint pains and permanent muscle damage just doesn’t provide that Russian-roulette adrenaline rush you want?  Or what if your darned LDL just refuses to drop to an insanely low level even though you’re chugging high-dose Lipitor every day?

Modern pharmacology to the rescue!

You’ve probably heard of PCSK9 inhibitors, the newest (ahem) wonder drug in the never-ending war against your body’s stupid tendency to produce cholesterol. Here’s how WebMD describes them:

PCSK9 inhibitors are proteins made in a laboratory. They target other proteins in your body, specifically your liver.

Your liver cells have receptors that sweep away excess cholesterol. But another protein called PCSK9 destroys them. That’s where inhibitors come in. They latch onto PCSK9 proteins and block them from acting. The result: More receptors are able to do their job. This lowers the amount of LDL cholesterol in your blood.

And here’s how the makers of Repatha, one of the PCSK9 inhibitors on the market, explain why you may need the drug:

Different types of treatments are used to lower high LDL bad cholesterol. Statins are the most commonly prescribed treatment, but sometimes your LDL is still too high.

Meaning you still have some LDL in your bloodstream.

You may need additional help or a different treatment option to lower your LDL.

Oh yes indeedy, you need that additional help. Because as we all know, beating your LDL cholesterol down to almost non-existent levels will save your life.

Additional is the key word here. The clinical studies have tested statins plus PCSK9 inhibitors vs. statins plus placebo. The subjects typically have familial hypercholesterolemia, which is why statins alone haven’t reduced their LDL cholesterol scores to a level that makes doctors smile.

And what do those studies show? Here’s the money quote from a meta-analysis of several studies published in the Journal of the American Heart Association (that would be the organization that wants us all to get our LDL cholesterol levels as low as possible:

Compared with no PCSK9 inhibitor therapy, treatment with a PCSK9 inhibitor was associated with a lower rate of myocardial infarction (2.3% versus 3.6), stroke (1.0% versus 1.4), and coronary revascularization (4.2% versus 5.8). Overall, no significant change was observed in all‐cause mortality or cardiovascular mortality.

Very much like studies of statins. A slight reduction in heart attacks and other cardiovascular events, but no reduction in deaths from heart attacks or any other cause.

A reader sent me a PDF describing the results of a study on Repatha specifically. The study, named FOURIER, included nearly 28,000 subjects. Half took their statins plus evolocumab (brand name Repatha), and the other half took their statins plus a placebo.

The drug did what it’s designed to do: beat down LDL. Whereas most of these people couldn’t get their LDL much below 100 (the supposed magic number) on a statin alone, adding Repatha into the mix drove LDL levels down to an average of 30. Wow! Almost no LDL left in the bloodstream at all! Boy, that must have really saved some lives, eh?

I’ll quote from the PDF:

Myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization occurred significantly less frequently in those taking evolocumab than in those taking placebo.

Well, okay then. Sign me up. But wait … I checked the numbers and ran some calculations in Excel. I’ll skip the detailed math and cut to the chase: we’re talking about possibly preventing one heart attack in every 100 people who took the drug. For strokes, it works out to possibly preventing four strokes for every 1,000 people taking the drug.

But here’s the result that really matters:

The two groups did not differ significantly in rates of cardiovascular mortality or all-cause mortality.

No lives saved. Actually, the mortality rates were slightly lower in the placebo group – just not enough to be statistically significant.

If you’ve already heard of PCSK9 inhibitors, you’ve probably also heard they’re expensive. The PDF included a cost-to-benefit section:

The authors estimate that 74 patients similar to those in the trial would need to be treated with evolocumab for two years in order to prevent one cardiovascular death, myocardial infarction or stroke.

Um … let’s correct that. According to both this study the AHA journal’s meta-analysis, the drug might prevent a heart attack or stroke once in a great while, but doesn’t prevent any deaths.  Zero. None. Again, the death rate was actually slightly lower in the placebo group.  So suggesting the drug would prevent any cardiovascular deaths at all is speculative at best and dishonest at worst.  Anyway, to continue:

The estimated cost of treating 74 patients with Repatha for two years is $2,149,400.

So there you have it. For the low, low cost of just over two million dollars, modern pharmacology allows doctors to treat 74 people with a drug that beats their LDL down to unnatural levels — and save zero lives as a result.

Ain’t it wonderful?

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44 thoughts on “How To Save Zero Lives For The Low, Low Cost Of Two Million Dollars And Change

      1. chris c

        Busted!

        There’s one possible way these things could work though. Buy shares in the manufacturers and use the profits to buy meat and butter.

        Reply
  1. Jeanne

    I want to RAISE my cholesterol not make it go lower. My last total was 160 which my doctor loved but not me.
    My HDL was 45, which I’m also not happy about, but at least my triglycerides were only 62.
    How does one raise it? I’m thinking more animal fats.

    Reply
    1. Tom Naughton Post author

      If you’re on a good diet and healthy, I wouldn’t worry about raising your cholesterol. I believe our bodies know what they’re doing.

      Reply
    2. Debby Verheyden, RN

      My HDL was 72…and Triglycerides were 110..well in the normal limits…but my LDL was a within normal limits to a little above normal and my internist was all over me again about putting me on statins. I again, gave her my reasons for NOT even thinking about them. Having read many articles on the subject (I am an RN), I gave her my reasons. She was still not happy. But, my life, my body..and my health is good on Keto diet! My A1 C is also now within normal…6…and I am a diabetic II…controlled by the Keto diet alone. NO medications. Read all the newest information. Lots out there. Cholesterol Clarity is a great guide…among others. My best to you all..

      Reply
  2. Walter

    When I tell people that Mad Magazine was the first burst of sanity in my early teens, I think they believe I’m joking.

    Human behavior hasn’t change or if it has it’s gotten worse. Probably because everyone (almost) has gone low saturated fat and high carb and the top decision makers being over 50 are on satins. Not to mention the oversizing of sodas.

    We don’t know what the replacements for transfats are doing,

    Reply
    1. Elenor

      This makes me think of my reaction to Nina Techoltz’s book. (Fascinating, a fun read, and horrific all at the same time!) When in a late,if not last, chapter she described how the makers of e.g., Cheezits (oh, a life-long love of mine, which I very very very rarely indulged in — but happened to have one of the big Costco double-bag boxes of, IN MY HOUSE as I read her book…) since they can no longer USE transfats (they have to list them, and too many folks had quit buying ‘foods’ (food-like objects) with transfats) — so they began MAKING UP fats; glomming stuff together trying to find a … a…. a SOMETHING that would ‘glue together’ the grains and stuff and provide the right mouth-feel. I took the box of (SO-beloved!) Cheezits out back and dumped them from the raccoons (sadly it did NOT poison them, but oh well!). And, to my almost amazement; I recoil from the box in the store… Box o’ poison, the shelf! (You CAN make a sort-of Cheezit with a slice of American cheese cut up on parchment paper in the microwave. {shrug} Amer. cheese may not be great, but it makes a crunchy cheese cracker-like thing.)

      But Nina’a book is very worth the read, and great at stiffening the spine against the horrors of the S.A.D.!!

      Reply
      1. Bob Niland

        Elenor: You CAN make a sort-of Cheezit with a slice of American cheese cut up on parchment paper in the microwave. {shrug} Amer. cheese may not be great, but it makes a crunchy cheese cracker-like thing.

        Here’s my recipe for that (PDF).

        Reply
  3. Kathy in OK

    I’ve seen the ads for Repatha. My question would be, at this price, who is going to take this drug? Other than the folks in the trials who don’t pay for the drug, of course. Would it even be included in most insurance formularies? Don’t they usually balk at covering new (meaning expensive & unproven) drugs? And the tier would be the highest, usually 5, which should be reserved for truly life-saving drugs. You know, the ones that if you don’t take them, you die really soon.

    Reply
    1. Tom Naughton Post author

      Doctors are balking at prescribing the drug because of the cost. I’ll bet someone somewhere is lobbying to have it covered by Medicare.

      Reply
      1. chris c

        In the UK they are lobbying to have it approved on the NHS for Familial Hypercholesterolemia. Then when the camel’s nose is in the tent they will attempt to widen the approval.

        Reply
  4. Dianne

    I wish to goodness some crusaders in the mainstream media would publish this kind of thing, but they’re doubtless too afraid of losing advertising dollars to consider it. Thank heaven big pharma and big food haven’t figured out a way to control what reaches people over the internet, though they’d no doubt like to. At least Time Magazine did tell us that it was OK to eat butter. But I don’t recall that they said anything negative about vegetable oils, and I haven’t seen any cover articles about the dangers of statins.

    Reply
      1. j

        Thankful for the internet. Were it not for, many would still be relying on the sole source of information, the propaganda megaphone. No more

        Reply
        1. Tom Naughton Post author

          There are pros and cons to the internet, but on balance, I think breaking the grip of the information gatekeepers has been positive. It was while conducting research online that I began to realize just how screwed-up the standard dietary advice is.

          Reply
    1. Drew @ Willpower Is For Fat People

      “The Florida Department of Health issued a cease-and-desist letter, and $754 fine, to a holistic health coach for sharing nutritional advice without a license.”
      https://articles.mercola.com/sites/articles/archive/2018/02/20/helping-people-eat-healthy-is-illegal.aspx

      “Two and a half years later the watchdog found he was working outside his scope of practise and was not qualified to give specific nutritional advice, and he was ordered to stop speaking about the low carbohydrate, high fat diet.”
      http://www.abc.net.au/news/2016-11-30/low-carb-advice-lands-doctor-in-hot-water/8078748

      Noakes just won his case (yay!) but they can definitely make it hard for people who can’t afford the legal fight.

      Reply
  5. Don from one of the Fattest States in America...Louisiana

    Great comments Tom! It makes me wonder what our healthcare system really could do if it wasn’t spending money on senseless research. Thanks for getting the info out!

    Reply
    1. Tom Naughton Post author

      Let’s just this say these drugs aren’t helping bring down the costs in a system nearly everyone believes is too expensive.

      Reply
  6. Steven Grajeda

    Goldman Sachs analysts attempted to address a touchy subject for biotech companies, especially those involved in the pioneering “gene therapy” treatment: cures could be bad for business in the long run.

    “Is curing patients a sustainable business model?” analysts ask in an April 10 report entitled “The Genome Revolution.”

    “The potential to deliver ‘one shot cures’ is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies,” analyst Salveen Richter wrote in the note to clients Tuesday. “While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow.”

    Reply
        1. Tom Naughton Post author

          I believe if people paid doctors directly for standard medical care, just like we pay plumbers and electricians, it would put some financial sanity back into the system. What we have now is the equivalent of expecting your car insurance to pay for gas, oil changes, tuneups, new tires and wiper blades.

          Reply
  7. Emily

    I feel like the idea that we need to beat down cholesterol to prevent hearts attacks is like the idea that we need to beat down white blood cell counts to cure pneumonia. Just nuts.

    Reply
    1. Tom Naughton Post author

      The summary:

      “Individuals with lifelong low LDL levels due to mutations in genes associated with increased LDL-LDL receptor (LDLR) activity reveal no safety issues. Patients achieving extremely low LDL levels in the IMPROVE-IT and FOURIER, and the PROFICIO and ODYSSEY programs seem not to have an increased prevalence of adverse effects.”

      Nothing in that summary suggests any benefit to artificially lowering LDL. As for not appearing to be detrimental, I’d question their definition of “detrimental.” The negative side effects of statins are known and real.

      Reply
  8. Jacqueline

    Hi Tom
    I’m desperate to get my perfectly healthy, but increasingly confused father off of statins. Can you recommend an accessible book about the dangers of statins? He has no internet access and will not listen to me. The man in the white coat told him he needs statins so
    he’s chugging them down every day and complaining of joint and muscle pain! It’s heartbreaking!
    Many thanks
    Jacqueline

    Reply
    1. Tom Naughton Post author

      “The Great Cholesterol Con” by Dr. Malcolm Kendrick. Very readable, and often quite funny.

      Reply
  9. BobM

    If you follow Twitter and particularly Ivor Cummins, there was a massive thread between anti-drug people (like Ivor) and cardiologists/drug proponents regarding statins and PCSK9 inhibitors and the FOURIER trial. The latest idea is that statins cause more plaque but “stabilize” it. Oh, and somehow the decrease in heart attacks outweighs the overall death rate (which, by the way, according to the proponents did not reach statistical significance) for FOURIER. It’s all in the way you spin it.

    But cardiologists are the last people (other than a few like Dr. Davis of Wheat Belly fame) to go against saturated fat and drugs. The AHA of course doesn’t help this.

    This is the way this entire area is, though: It’s “slippery”. The cholesterol hypothesis in particular is bad this way: First it was total cholesterol = bad; then HDL good, LDL bad; “oxidized” cholesterol = bad; LDL/HDL subfractions are bad or good, as the case may be; TC/LDL or TC/HDL or TC/trigs or LDL particle count or… is what really matters. You can’t pin it down.

    And I know that by fasting or other actions not entirely clear to me, I can dramatically change my values. Most if not all studies assume these are fixed over large swaths of time, and that’s simply not true.

    Basically, you start with a result, then go find the data that meets your result. You’ve “proven” your thesis. It’s the same with nutrition.

    Reply
    1. Tom Naughton Post author

      Yup. Dr. Kendrick did a wonderful job in “The Great Cholesterol Con” of detailing how the Lipid Hypothesis has been changed several times to avoid just dumping it.

      Reply
      1. chris c

        I think it was Peter at Hyperlipid who pointed out that the REAL culprit was the sky blue pink cholesterol with polka dots.

        Reply
  10. Gerard

    Love your work Tom. Tell me, is your view on cholesterol at all nuanced. Keto delivered wonderous results to me but cholesterol went up. I went through so much stuff including dietdoctor videos, you name it. Better be safe than sorry. I got so confused, every paper I red on the matter found either no correlation or perhaps another metric might better predict heart attacks. But each time the regression analysis wasn’t all the great. I found papers looking into things like – LDL, LDL/HDL ratios, LDL/Triclyerides ratios, LDL-C vs LDL-P just to name a few. They might not be all the metrics – just thinking off my head. Mark Sission had a great page – https://www.marksdailyapple.com/how-to-interpret-cholesterol-test-results/ …… but with no real answers. Im wondering, do you care at all about your cholesterol results? Or do you have some nuanced view on the subject? Would you in theory be happy if your doctor said “wow, you LDL has shot down”… Personally I like my triglycerides low, though my GP seems indifferent compared to her take on LDL. You know the awesome page you did on veganism? Where you point vegans who send you emails. Would be so awesome if you could collate your over view about cholesterol. A lot of different LC view points float around since your awesome movie. I would be keen on your over all view.

    Reply
    1. Tom Naughton Post author

      It’s a bit nuanced. I believe what matters more than any particular number is whether the LDL is oxidized. Since LDL that’s large and fluffy and not oxidized may be protective against cancer and infections, I wouldn’t clap if my doctor said my LDL went down.

      Of course what really matters is whether or not you’re building up plaque in your coronary arteries. A calcium score (which I’ve never had) is a more direct measure than any cholesterol test.

      Reply

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