More Very, Very Bad News For Statins

      44 Comments on More Very, Very Bad News For Statins

As if you need another reason to avoid statins …

A couple of readers sent me a link to the latest post by Dr. Malcolm Kendrick, which is titled Statins and Amyotrophic Lateral Sclerosis. (You may have heard ALS referred to by its more common name, Lou Gehrig’s Disease.) Let’s take a peek:

With ALS, your brain remains unaffected, whilst your body dies around you. People suffering ALS are often the ones you see in front of the High Court asking for a change in the law, so that they can be assisted to die, rather than suffocating to death. Thus far, in the UK, the courts have remained impervious to basic, caring, humanity. [You may infer what my views are on this matter].

Now, I have known for many years that statins are likely to cause damage to nerve cells. Probably through a direct effect on inhibiting cholesterol synthesis. Synapses are made, primarily, of cholesterol. Cholesterol is required to maintain the health of the myelin sheath, that surrounds and protects neurones. Glial cells in the brain, sustain the myelin sheath by synthesizing their own cholesterol and transferring it across to neurones, and suchlike.

A couple of weeks ago I was sent the following paper that was published in the Journal Drug Safety. ‘Amyotrophic Lateral Sclerosis Associated with Statin Use A Disproportionality Analysis of the FDA’s Adverse Event Reporting System.’

You can read a summary of the study Dr. Kendrick analyzed here. He apparently has the full-text version and pulled out some interesting (or horrifying, if you prefer) findings. The paper lists the relative risk of developing ALS among statin-takers compared to the general population. As Dr. Kendrick explains:

An odds ratio, basically means increased (or decreased) risk of something happening relative to the standard risk of one. An odds ratio of two (2) means something is twice as likely to happen. An odds ratio of nine (9) means something is nine times as likely to happen. This can also be represented as 900% increase in risk.

Stripping these figures out, we find the following increased risk of ALS associated with the use of different statins. Some statins are more likely to enter the brain than others (atorvastatin, simvastatin and lovastatin) because they are lipophilic (attracted to lipids), these ones had higher ROR.

He listed the odds ratios in a table, so let me just summarize in words: compared to the general population, people taking Rosuvastatin (brand name Crestor) are nine times as likely on average to develop ALS. Horrifying, right? Actually, that’s on the low end of the spectrum. For Atorvastatin (Lipitor), the odds ratio is 17. For Simvastatin (Zocor), the odds ratio is 23 – again, that means people taking it are 23 times more likely on average to develop ALS. But wait, it gets even better. For people taking Lovastatin (Mevacor), the odds ratio is 107.

Two questions may have already popped into your mind. Here’s the first: since this is just an observational study, should we be concerned? I’ll let Dr. Kendrick answer that:

It is often said that association does not mean causation. However, this is only true up to a point. Most statisticians agree that an odds ratio > 6 represents proof of causation. When you find that people taking atorvastatin have a seventeen-fold increase in risk of ALS, this is proof of causation. The effect is too massive to be due to anything else.

A lot of the scary headlines produced by observational studies are based on what looks like a high risk (people who eat bacon are 20% more likely to develop bunions!) but isn’t – 20% more likely in this case would mean an odds ratio of 1.2. Nowhere close to 6.0.  We can and should ignore associations of that variety.

But in this study, we’re talking about odds ratios ranging from 9.0 to 107. I’d pay attention.

The second question: why aren’t doctors beating down the doors of health agencies to scream that statin patients are developing ALS at an alarming rate? I’ll let Kendrick answer that as well:

Now, you may think this is one hell of a lot of people, surely someone would notice. In truth, an increase like this is unlikely to be spotted by anyone. Looking at the UK, each year you might expect to see an extra 3425 cases of ALS each year.

There are around fifty thousand General Practitioners in the UK. So, each GP might expect to see an extra statin related ALS case every sixteen years or so. Or a maximum of two in their working life. You would have to be exceptionally alert to associate one extra case of ALS every sixteen years to statin use.

Doctors aren’t noticing because a 23-fold increase in a very small number is still a small number.  Dr. Kendrick did the math:

In short, in a population of fifty million people, not taking statins, we can calculate that around 1,250 would develop ALS every year.

On the other hand, in a population of fifty million people taking statins (atorvastatin and simvastatin) we can expect that figure to be multiplied by around twenty. Now instead of 1,250 people developing ALS, we can expect to see 20 x 1,250 = 25,000.

Still a very small number in absolute terms. Divide 25,000 by 50 million and you get 0.0005, or one in every 2,000 statin-takers.  The study isn’t saying if you take a statin, you’re highly likely to develop ALS.  It’s saying the small odds are multiplied.

But then again, the supposed life-saving benefits of statins are also very small. Even the most positive studies (which are certainly cherry-picked) suggest perhaps 1 in 100 people taking statins will avoid a heart attack – but only if they belong to a narrowly-defined group at high risk.

Here’s what one study said about how long statins actually prolong life:

The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively.

Wow. A few extra days on average. Now balance that against the risks of muscle and joint pains, permanent muscle damage, diabetes, liver damage, memory loss and perhaps ALS.

And that’s why I once told a doctor who suggested I might try a statin to lower my (ahem) “high” cholesterol, “I wouldn’t take a statin unless you had a gun to my head and I was convinced you’d pull the trigger.”

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44 thoughts on “More Very, Very Bad News For Statins

    1. Tom Naughton Post author

      I hadn’t seen Dr. Fung’s post before. The corruption of science isn’t surprising to me at this point, but nonetheless disgusting.

      MS, Parkinson’s, who knows? I suspect messing with your body’s cholesterol can have all kinds of nasty effects yet to be studied.

      Reply
    1. Tom Naughton Post author

      Very nice analysis, Andres. Thanks for the link. Even if we extend the supposed benefits beyond the trial period, as in your analysis, I’m not seeing numbers that would convince me to take a statin. You obviously agree.

      Reply
  1. Jack Simmons

    I do not take statins because no one has demonstrated the connection between cholesterol levels and heart health. In fact, some evidence of higher mortality rates for lower levels of cholesterol.

    Instead, I am convinced heart disease is connected to inflammation and low collagen production. To reverse this, I take lypospheric Vitamin c.

    Reply
    1. Andy

      LOW collagen?!?! Coronary Fibrosis is CAUSED by overstimulated collagen production.

      “Fibrocyte cells normally secrete collagen, and function to provide structural support for the heart. When over-activated this process causes thickening and fibrosis of the valve, with white tissue building up primarily on the tricuspid valve, but also occurring on the pulmonary valve. The thickening and loss of flexibility eventually may lead to valvular dysfunction and right-sided heart failure.”

      https://en.m.wikipedia.org/wiki/Cardiac_fibrosis

      Reply
  2. Kurt

    I’m not as quick to dismiss the observational nature of the study. Do you happen to know if the study group included only those prescribed statins? This would at least smooth out the con-founder of prior health status. I suspect doctors are less likely to prescribe statins to an obviously healthy person even if they have elevated total cholesterol.

    Reply
    1. Tom Naughton Post author

      Actually, I’m one of countless people doctors have wanted to put on statins for no other reason than a cholesterol reading above 200. It’s happened to me twice, two different doctors. Checkup shows no health issues, doctor sees cholesterol above 200 (with high HDL and low triglycerides), then suggests a statin to get the cholesterol below 200.

      Reply
  3. BobM

    Malcolm Kendrick also has a post on his site about how statins don’t “prevent” death; instead, they only delay it. The amount of time they delay it, even using the most favorable studies, is a few days per year.

    Reply
  4. MLCDz

    I have lost two friends, and know of two other friends whose relatives have developed ALS in the last 10 years. I’d never heard of it before that other than Lou Gehrig having it. To be that close to it when no one could figure out where it came from – it wasn’t in their family I now wonder if they were on statins. my bet would be yes. Thank you for this public awareness article.

    Reply
    1. Tom Naughton Post author

      Given that doctors prescribe statins like they’re handing out candy, there’s a good chance they were on them.

      Reply
      1. KidPsych

        This also leads me to wonder about people who might not fall into a diagnosable category, yet might show symptoms of ALS or some other degenerative illness.

        This caught my eye today. (File under health is bad for profits.)

        https://gritpost.com/goldman-sachs-illness-business/

        FTL: ““[Gilead] is a case in point, where the success of its hepatitis C franchise has gradually exhausted the available pool of treatable patients,” the report read. “In the case of infectious diseases such as hepatitis C, curing existing patients also decreases the number of carriers able to transmit the virus to new patients, thus the incident pool also declines … Where an incident pool remains stable (eg, in cancer) the potential for a cure poses less risk to the sustainability of a franchise.”

        The Goldman Sachs report’s conclusions about the declining profitability of curing patients’ illnesses flies in the face of conventional capitalist thought.”

        Reply
  5. Kathy in OK

    Every time I read something like this, I’m reminded that today’s children are the first generation expected to have a shorter lifespan than their parents. And the diseases that will kill them are often horrific, degenerative diseases like ALS, MS and Parkinson’s.

    Reply
    1. Tom Naughton Post author

      It’s stunning, isn’t it? We’re less likely to be murdered or die in a work accident than at any other time in history, and we’re killing ourselves with bad food and bad drugs.

      Reply
  6. June

    Devil’s advocate here:
    How do these numbers compare to studies showing , say, a connection between eating meat and some disease that says “Eating meat raises your chances of dying of Horrible Disease by %500”, but it really means that instead of one person per (math) getting the disease there will be two people per (math) getting the disease and the actual chances of you getting the disease in the first place are quite low. I only ask because one of the things we’ve been trained to look for is when risk factors are expressed in terms of Relative Risk vs Absolute Risk vs Hazard Ratio. When they use Relative Risk they are possibly trying to inflate the sense of danger from the thing being studied.

    I ask because there is a danger in accepting information that reinforces your personal views without giving it the same scrutiny you give to information that goes against your personal views.

    Reply
    1. June

      For the record, I also refuse to take statins, much to my doctor’s concern. My labs come in and my doctor recommends going on statins and I explain that my Triglyceride/HDL ratio is just fine and she points out that I’m a Type 2 Diabetic and at increased risk for heart disease and I point out that statins may have put me into diabetes and then we go on and repeat in 3 months.

      Reply
    2. Tom Naughton Post author

      Agreed, which is why Kendrick went through the numbers. Most of those scary headlines based on observational studies are more along the lines of “eating meat increases you risk of heart disease by 50%!” … which means a risk ratio of 1.5. When we see risk ratios of 9.0 or 23.0, that’s a different animal.

      The link between smoking and lung cancer was accepted because of high risk ratios in observational studies. Obviously nobody was going to recruit non-smokers into a clinical study and have them smoke for 20 years to track the cancer rates.

      Reply
      1. June

        My other concern is that I can’t get from Dr. Kendrick’s article if the original paper is talking about the number of people who develop ALS and report statin use or if it’s the number of people using statins who have developed ALS. If it’s the former, it doesn’t show causation necessarily. ALS is primarily diagnosed in people over age 55, which is also the prime age where doctors put people on statins, so of course there are more people reporting using statins who have ALS. If it’s the latter, yeah, that’s a concern, but how complete is the data? Since ALS isn’t a reportable disease, there could be selection bias in any voluntary reporting to government agencies.

        There’s also the difficulty in determining if there has, in fact, been a rise in ALS since the introduction of statins 20 years ago. Dr. Kendrick admitted he couldn’t find a clear pattern, partially due to the fact that it’s not a reportable disease. The CDC has an ALS Registery since 2010, but it’s voluntary, so there’s selection bias. Patient advocacy groups are usually the first to start sounding the alarm about an increase in disease rates or prevalence because it can lead to increased research funding, but I didn’t see anything on the ALS Association site about an increase. They actually said the prevalence was down a bit from projections, but they attributed it to some groups being less likely to report.

        I am still gently arguing with my doctor about why I won’t go on statins and I am trying to find good research articles to back up my position, but this isn’t an article I’ll be using.

        Reply
        1. Tom Naughton Post author

          It would be interesting to see the full paper. The author listed first, Beatrice Golomb, has been running a project to track statin side effects for years … without industry funding, of course.

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

    This is absolutely horrifying! Seriously…I may go to sleep at night having nightmares! What I find very disturbing, however, is that the “Amyotrophic Lateral Sclerosis Associated with Statin Use” study is not available to read unless you pay $50! Why isn’t this information offered to the general public? I doubt very few would read it anyways, but that’s on them. I myself want to know that if I take something that is supposed to make me better, I might actually develop a debilitating disease! Thank you Tom for getting this information out there!

    Reply
    1. Tom Naughton Post author

      Most full-text studies aren’t available to the public, unfortunately. At least not legally.

      Reply
  8. jolly

    For those with heart disease, I’d recommend looking at the youtube videos of Ford Brewer, MD. He’s head of Johns Hopkins Preventative Medicine, and he’s the only MD that seems to have a reasonable viewpoint on supplements, inflammation, statins, and alternative meds.
    My main two sources of info on cardiac disease is Tom Naughton’s references, and Dr Brewer’s. They are not in complete congruence, but overlap much more than average. I have even managed to drag my cardiologist into checking-out Dr Brewer’s channel as well.
    The one thing that hooked me on Dr Brewer’s channel was his assertion that he reduced his own “plaque age” by 20 years by following a supplementation and very-low-dose statin regimen. Yes, statin. I have had a heart attack, and very recently showed that I was clogging-up again very quickly. I was weeks away from another heart attack.
    I’m rolling the dice and taking Ford Brewer’s regimen for six months to see if it helps. I do not have blood sugar problems, and have gone to low carb in earnest. Fingers crossed.

    Reply
      1. Bob

        Good luck, indeed.

        I have a friend who has had five coronary stenting procedures and one carotid stenting procedure in less than 20 years. All of the coronary stents have been in the right coronary artery. Some of her older stents have themselves been stented. Her other arteries are clean, despite smoking and diabetes. She takes a statin and other medications (such as blood thinner).

        It’s remarkable diet could be considered a culprit and statins a benefit when her disease is so focused on a single artery. Certainly one of the mysteries of CVD.

        Reply
  9. Walter

    Quote

    What are the clinical implications of our findings? We believe that statins should be prescribed according to the prevailing guidelines. Statins are usually inexpensive and safe, at least in a clinical trial setting,20 and the benefit in terms of mortality or non-fatal cardiovascular outcomes cannot reasonably be challenged.

    End Quote

    Chez Watt?

    I suppose they had to reach that conclusion

    Reply
    1. Emily

      It’s just like a huge study I read years back that found that people in the “overweight” category of BMI were healthier and lived longer than those in the “normal weight” category. It also found that “normal” weight and “obese” people were about equal in health — basically that the BMI should probably be moved up a notch if we were gonna keep insisting on using it. They ended with saying something like “this confirms the need for everyone over ‘normal’ weight to lose weight.” Which of course it didn’t at all, but they couldn’t say that, probably because the weight loss industry would get mad.

      Reply
  10. chris c

    Did you know Lou Gehrig died from Lou Gehrig’s disease. There’s a coincidence! (Steven Wright I think)

    These numbers are totally scary, although the result of a huge increase of a rare disease may not involve many people they show clearly that something is going on that seriously needs to be researched.

    A neighbour died of this, such a lovely guy and such a horrid way to go. His widow moved away or I’d ask if he was on statins – I suspect he was simply because he was over sixty.

    Reply
    1. Tom Naughton Post author

      It’s a good guess that he was taking statins, since the AHA seems to believe nearly everyone should be taking them.

      Reply
  11. Angel

    I just overheard a conversation a few days ago between two elderly men. One of them talked about having two doctors who were disagreeing over his statin prescription. One of them said, “Your cholesterol is in the 120s, it’s way too low, you need to get off statins.” The prescribing doctor said “no way”. This man thought the prescribing doctor was doing him a favor.

    Reply
    1. Tom Naughton Post author

      Cholesterol of 120?! No thanks. At least one doctor recognized that cholesterol can be too low. Too bad he’s the one who will likely be ignored.

      Reply
      1. Firebird7478

        I was in the waiting room at my chiropractor’s office and heard a patient tell the receptionist how she was using Shaklee vitamins and herbs to lower her cholesterol. The woman had to be in her mid-60s. I had to bite my lip to refrain from saying anything.

        Reply
          1. Firebird7478

            She said something to the effect that there are “statins” in nature…natural cholesterol lowering foods. I guess she was referring to rice yeast extract.

            Reply
  12. Angel

    Also, I’m a female in my mid 40s, and I was recently told by a very young female doctor that I need to start taking a statin (total cholesterol above 200). I had hoped that since she was so young and a DO, that she would be willing to think outside the box. But she was quite firmly in it.

    Reply
  13. Firebird7478

    I have read a few news items that suggest ALS is a gut issue. I read “The Luckiest Man”, Lou Gehrig’s biography. He spent a lot of time at the Mayo Clinic. They treated him with Vitamin E and they had positive, albeit temporary, response to it, but they could not keep it from getting worse. They blamed it on Gehrig’s workout regimen. He was a fitness fiend for his time. He’d play in a double header then take his boat out onto Jamaica Bay and go for a row at night.

    The stats he put up even though he was showing early signs of the disease are astonishing. Even in his last full season, when the writers were ripping him (they didn’t know he was dying) he was still putting up numbers that were career years for lesser players.

    The letters between Gehrig, his personal doctor and the doctors at the Mayo Clinic are very revealing. The man truly believed he was going to get better, and you can see it in his attitude during his speech at Yankees Stadium.

    Reply
  14. Chantelle

    My ALS (amyotrophic lateral sclerosis) symptoms started out with muscle weakness, stiffness and slurred speech. My primary physician prescribed riluzole and radicava to reduce symptoms and slow down the disease progress, I could not take them for long because of the terrible side effects. So i adopted a more natural approach and started on ALS Herbal formula from RICH HERBS FOUNDATION, the ALS natural formula immensely helped my condition, i had a total recovery from ALS with this formula treatment. Their official web-site w w w. r i c h h e r b s f o u n d a t i o n. c o m. I feel so much alive again!

    Reply

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