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More Expensive, Ineffective Cholesterol-Lowering Medications Now Being Touted


On March 10, 2018 at the annual American College of Cardiology (ACC) meeting, an “on the scene” video  was released reporting the results of the new PCSK9 cholesterol-lowering medication Praluent. (1)  This new class of LDL-cholesterol lowering medications works differently than statins.  PCSK9 inhibiters block an enzyme naturally produced in the body—PCSK9—which can dramatically lower LDL-cholesterol levels.  PCSK9 inhibitors are more effective at lowering LDL-cholesterol levels than statin drugs.

I have written about the failure of statin drugs in many blog posts and in my book, The Statin Disaster.  When I published that book, I predicted that PCSK9 inhibitors would prove to be no better than statin drugs at preventing heart disease.  Remember, statins are about 1% effective, in the best of the studies, at lowering one’s risk for heart disease. 

The trial reported at the ACC meeting (1) compared the safety and efficacy of Praluent compared with placebo among patients with recent acute coronary syndrome already on intensive or maximum tolerated statin therapy.

In the video, the doctor stated (slightly parapharased) that the bottom line is simple: First, there was a 15% reduction in MACE (major adverse cardiac events) defined as coronary heart disease deaths, MI (heart attacks), stroke and unstable angina.  The bonus finding was that there was a 15% lower all-cause mortality risk…in the treated group compared to placebo.

Let’s look at this data.  For MACE, the treatment group had an outcome rate of 9.5% and the placebo group’s outcome rate was 11.1%.  The relative risk difference is 15% (9.5/11.1).  However, I have been writing and lecturing for well over 15 years about why relative risk data should never be used for clinical decisions.  Relative risk analysis is used by Big Pharma to make a poorly-performing drug or therapy appear better than it actually is.  When making a clinical decision, a healthcare professional should use the absolute risk differences so that he/she can determine how many patients need to be treated with the drug to prevent the outcome desired.  In this case, the absolute risk difference to prevent MACE is:  1.6% (11.1%-9.5%).  A better representation of the data would state, “The use of Praluent for 48 months (the length of the study) resulted in a 1.6% decline in MACE.  In other words, the drug failed 98.4% who took it.”  Furthermore, 62 patients would need to be treated for 48 months with Praluent to prevent one MACE. 

How much does it cost to prevent one case of MACE using Praluent for 48 months?  Praluent costs $14,600 per year.  To prevent one MACE, 62 patients  would have to be treated for 48 months.  The cost would be:  62 x 48 x $14,600 = $3,620,800.

Boy, that sounds like a cost-effective therapy to me.

Let’s look at the second point in the video—all-cause mortality.  The difference between the treatment and placebo groups was 3.5% versus 4.1%.  The relative risk difference is 15% (3.5%/4.1%).  The absolute risk difference is 0.6% (4.1% – 3.5%).  That means 166 patients would need to take Praluent for 48 months to  prevent one death. 

How much does that cost? $14,600 x 4 years x 166 patients = $19,694,400.

What a deal.

Folks, I did not even get into the side effects of PCSK9 inhibitor drugs here which include an increased risk for infections, diabetes,  and mental decline.  All of these adverse effects are easily predicted by looking at the mechanism of action of PCSK9 inhibitors.  

I think we could spend our scarce health dollars much better than on PCSK9 inhibiters.  I will go out on a limb and state that teaching people to eat better and drink water would provide better results at a much lower price than PCSK9 inhibitors.

I would like to know how the FDA can approve poorly-performing drugs like PCSK9 inhibitors. All the more reason for President Trump to start draining the swamp of the FDA.  

More information about why you should not take statin drugs or PCSK9 inhibitors can be found in my book, The Statin Disaster.

I would like to hear from any cardiologists out there.  Any comments/opinions, pro or con, are welcome. DrB


Author Info

David Brownstein, M.D.

Comments ( 21 )

  • Author Icon

    I had a heart attack 2 years ago. I’ve been fighting the cardiologist about taking statins. I have high LPa which is an independent risk for heart attacks. Now my dr wants to put me in praluent. I’m so confused. My total cholesterol is 228 and my LDL is 125. LPa is 177. Where do you practice Dr Brownstein?

    • Author Icon

      Statins do nothing for elevated LPa. Vitamin C helps this. I practice in West Bloomfield, MI.

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    Rick Ludeman

    I think your point about relative risk as a misleading measure is well taken. You suggest instead the conclusion should be, “The use of Praluent for 48 months (the length of the study) resulted in a 1.6% decline in MACE. In other words, the drug failed 98.4% who took it.”

    I see two problems with your recommended revision.

    1) How can you say the drug failed someone who didn’t have a MACE? Your reference to 98.4% seems like hyperbole and undermines your point.

    2) The difference is 1.6 percentage points, not 1.6%. The drug company is correct that the decline is 15% (actually it appears they rounded up as 1.6/11.1=14.4%). However, I agree with you that without the full context of the actual figures this seems like a cynical exaggeration of the true effect.

  • Author Icon
    Merinda Reid

    I wish more people would listen to you. My cousin had triple bypass surgery and it took 5 months to clear up the infection in her leg where they took the veins. Healing was very slow due to her having Lipitor induced diabetes.

  • Author Icon
    William Redfield

    As usual, Dr . B has concisely assessed the alleged claims by the manufacturer of this new treatment. It’s saddening to no end that the General Public is unable to discern myth from physiological requirements relating to cholesterol. It appears as though we have been brainwashed to believe that cholesterol is incredibly evil. As Dr. B has written nothing could be further from the truth. Many neurological and vascular diseases are symptoms attributed to a living being’s reaction to staying alive.

    While diet is one factor to living a healthy long life it seems readily Apparent, at this point, the Transport Systems for the foods and supplements we consume are far more affected by the water we drink. If the water we consume is contaminated at any point in time, regardless of the level of filtration, the cellular activity will be adversely affected.

    When the patient is experiencing energetic blockages caused by chronic tooth infections and emotional trauma water will fail to deliver the necessary minerals and cholesterol to support / energize cellular function wherever the blockage exists.

    The holistic approach encompasses all the disciplines Dr. B is teaching. He has committed his life to educate people on taking an active role in their own health. This may be accomplished by a lifelong journey to studying and experimentation. I encourage everyone to read all his books.

  • Author Icon
    L. K.

    Does Repatha fall under your PCSK9 concerns?

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    Jennifer Lee

    Dr. Brownstein, do you know of a Holistic Doctor near Portland Oregon that you would endorse? My brother aged, 61 had a stroke on Feb 6, 2017. He was placed on a statin, anti-seizure medication, a loop recorder was placed in his heart. His only deficit was short term memory loss, he physically had no issues and we are glad for that. He was diagnosed with Type 2 Diabetes and placed on Metformin. He is having problems with the statin and exhibits bone pain as well problems at times with his memory. He had therapy for months and did puzzles with the therapist and home work assignments. Overall, he tells us he does not feel well and I was wondering if you would take a stroke patient off of a statin. His blood work is now fine from what I have been told The statin is beginning to produce problems and I would like for him to get off of it and the metformin. I know you cannot diagnose but perhaps if you knew of a doctor it could help us.

    Many thanks,

    • Author Icon

      Hi Jennifer, I am no doctor but my mother suffered a stroke at the age of 83. She was not on any medication until then. Her stroke was due to AFIB diagnosed by a 30 day heart monitor. As a rule she is very sensitive to medications and having side effects. I purchased pretty much all of Dr. Brownsteins books and read them from cover to cover. The only thing my mom is on now, five years later is a blood thinner. While on a statin, her cholesterol went to 117, on Metformin she was having cold extremities and feeling dizzy, while on AFIB medication her blood pressure went so low she passed out at the dentist office and had to be rushed to emergency. I was the one who talked to her internist about taking her off Metformin and the statin and had his support. He said if her blood sugar stayed under 120 he would keep her off, he said if her blood pressure stayed as a rule, 150/90 or below he was fine with that but she is still on the blood thinner to protect her from another stroke. The AFIB is still there but is “controlled” whatever that means and has regular EKG’s and ECG’s and goes to the cardiologist twice a year. You will find with a stroke victim that a lot of their symptoms are due to the damage done to their brain and medications may make it worse. My husband was placed on a statin 15 years ago and started to have the side effects of brain fog and neuropathy in his feet. His cholesterol was in the high 200’s, again reading Dr. Brownstein’s book on Statin Drugs encouraged me to suggest he have a Calcium Score test done to show what his ratio is and if he has any plaque in his arteries. The test came back perfect so he was able to go off the statin and he even educated his cardiologist a little about how cholesterol isn’t such a bad thing.. These are my stories and I am not suggesting your brother do anything without educating himself and talking to his doctors. If he doesn’t have a holistic doctor, I strongly suggest checking into one.

  • Author Icon
    Jane C

    Dr. B, How can I get my husband to get off all his meds. Statins, asthma inhaler, gout meds and has been on lipitor on and off in the last few years. He’s anxious, 15 -20 lbs overweight, goes to the gym but is inconsistent with his diet. I see a cognitive change over the last year with serious memory issues, cannot use can opener without lots of difficulty and also wine bottles. He can’t back up the car and has become more disorganized . I have tried to get him to go to a neurologist or holistic MD in our area but he’s resistant. He takes no supplements as well. Any suggestions would be appreciated. I threw out the statins, changed my eating habits and lost 30 lbs, all my blood work improved to normal and I take supplements. I am 70 and he’s 70 also. He retires end of April and has been a high functioning very successful man his entire life. Has
    OCD, ADD forever!

    • Author Icon

      The best advice I can give you is to find a good holistic health care provider. He/she can help your husband’s condition.

  • Author Icon

    Forget statins. Eat a teaspoon of crushed garlic and one cup of fresh blueberries every day. I did this and lowered my cholesterol 62 points.

  • Author Icon
    Grover Syck

    Like a political book title put it.
    Damn lies,
    and Statistics.

  • Author Icon
    Mary Nelson

    Years ago I decided I would not take any statin drug.
    I had some possible heart issues close to a month ago. I was referred to an invasive cardiologist.
    He ordered a beta-blocker. It wiped out my energy AND it immediately started raising fasting glucose levels. The first day I had taken a whole tablet. The 2nd, 1/2. I reduced more each day to where I only took a total of 4 tablets over about a week when I stopped.
    If it takes a drug known to cause diabetes per an article in a UK newspaper a few years ago to help my heart, WOW! That fits with statin results as well.
    Not sure how brain might have been injured in such a short time.
    Don’t they know how to create something that is not so harmful at all?????

    • Author Icon

      There is no need to create for many–lots of natural things have been created for us.

  • Author Icon
    Roger Martindill

    As always Dr B, you analyze the data and put the truth out for us.

    I am using supplements produced by the People’s Chemist and have stabilized my cholesterol and BP with satisfaction.
    Even my primary physician has committed on my stable blood work.

  • Author Icon

    Well done as usual with 1 caveat. NNT is time dependant. An NNT will seem artificially high of you are studying a disease that takes 40 or more years to evolve, over a 2 year time period. So, for example , if a drug shows an NNT of .6 percent over 2 years , and you extrapolate the results to 40 years, the NNT would be 20 x .6 or 12 percent. Still low but the patient should be told that if they took the drug for 40 years they would have a 12 pc absolute risk reduction. Many cardiologist justify statins like this. Always match or extrapolate the NNT to the natural history of the endpoint disease evolution time.

    • Author Icon

      Dr. G,
      Yes, you are correct. BUT, it is an assumption that the benefit will continue over time. How do you know the benefit will continue? Over a long period of time, adverse effects may accumulate as well.
      Statin drugs have been around for over 20 years, if there is a one percent benefit per year (which there isn’t), we should have data that statins have now (20 years later) been shown to have a 20% benefit at lowering heart disease risk. We don’t have that data. Statins and these new drugs fail the vast majority who take them. I simply don’t understand how they stay on the market when you factor in price and adverse effects.

  • Author Icon
    Bev D.

    People want to believe that they need Statins – after seeing our neighbor spiral downward because of “Lipitor toxicity” I would never support someone I care about taking them. He is not the same since this happened.

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