New Statin Warnings

      172 Comments on New Statin Warnings

Better late than never.  The FDA is finally admitting there are problems with statins:

Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, the cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain.

It is the first time that the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years.

I guess now that the patent is expiring on Lipitor, the FDA suddenly realized those problems people have been reporting for years deserve some attention.  But hey, let’s not panic and stop taking these marvelous drugs just yet, folks:

But federal officials and some medical experts said the new alerts should not scare people away from statins. “The value of statins in preventing heart disease has been clearly established,” said Dr. Amy G. Egan, deputy director for safety in the F.D.A.’s division of metabolism and endocrinology products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

Diabetes patients and even those who develop diabetes while taking statins should continue taking the medicines, said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who has studied the medicines extensively.

“These are not major issues, and they really do not alter the decision-making process with regard to statins,” Dr. Nissen said.

I see … so developing diabetes isn’t a major issue now – certainly not a big enough issue to stop giving statins to women, the elderly, men without any pre-existing heart disease, or any of the other groups who haven’t actually been shown to benefit from them.  After all, those side effects are rare.

And how do we know the side effects are rare?  Because the medical literature says so, that’s how.  Surely any study that appears in the pages of a respected medical journal has been carefully vetted for accuracy and unbiased conclusions, right?

Hardly.  The video below is of a lecture by Beatrice Golomb, an associate professor of medicine at the University of California-San Diego, on how pharmaceutical companies have corrupted medical science.  I urge you to watch the entire 20 minutes:

What she describes in her presentation is very similar to what I read in a terrific book titled Anatomy of an Epidemic, which recounts what’s happened to mental health in America since all those lovely psychiatric drugs were introduced years ago.  (Hint:  rates of mental illness haven’t improved.  Quite the opposite.)  The author, Robert Whitaker, devotes an entire chapter to how pharmaceutical companies manipulate studies to exaggerate the supposed  benefits and minimize the incidence of side effects.  As just one example, researchers will try putting prospective subjects on a drug before the official study begins. Those who have negative reactions are excluded.  Well, duh … if you bump the people who exhibit side effects ahead of time, you’ll almost certainly be able to report few side effects at the end of the study.

I sincerely doubt the side effects of statins are as rare as we’ve been told.  Back in 2008, the Wall Street Journal ran an article suggesting that statins might not be so great for the brain.  Here’s a quote:

“This drug [Lipitor] makes women stupid,” Orli Etingin, vice chairman of medicine at New York Presbyterian Hospital, declared at a recent luncheon discussion sponsored by Project A.L.S. to raise awareness of gender issues and the brain. Dr. Etingin, who is also founder and director of the Iris Cantor Women’s Health Center in New York, told of a typical patient in her 40s, unable to concentrate or recall words. Tests found nothing amiss, but when the woman stopped taking Lipitor, the symptoms vanished. When she resumed taking Lipitor, they returned.

“I’ve seen this in maybe two dozen patients,” Dr. Etingin said later, adding that they did better on other statins. “This is just observational, of course. We really need more studies, particularly on cognitive effects and women.”

Now … if one doctor has seen memory problems in two dozen women, how rare can that side effect be?

Dr. Etingin at least noticed the connection.  Many doctors don’t.  When elderly people complain of muscle pain or memory loss, doctors often write it off as the usual complaints of old age.  As I’ve mentioned in previous posts, my mom had frequent muscle pains while taking statins, but her doctor never made the connection.  I did.

Here’s more from the Wall Street Journal article:

Thinking and memory problems are difficult to quantify, and easy for doctors to dismiss. Many people who take statins are elderly and have other conditions and medications that could have cognitive side effects.

Still, the chronology can be very telling, says Gayatri Devi, an associate professor of neurology and psychiatry at New York University School of Medicine, who says she’s seen at least six patients whose memory problems were traceable to statins in 12 years of practice. “The changes started to occur within six weeks of starting the statin, and the cognitive abilities returned very quickly when they went off,” says Dr. Devi. “It’s just a handful of patients, but for them, it made a huge difference.”

Six patients in 12 years isn’t a staggering number.  But Dr. Devi probably noticed those cases because the cognitive problems showed up so quickly, then faded quickly when patients stopped taking statins.  What about people who don’t suffer mental problems immediately?  Could statins cause a long, slow decline in other people that doctors don’t attribute to the drugs?

I certainly think so, based on personal experience.  The picture below is of me visiting my dad at Christmas.  He’s 77 years old and hasn’t recognized me in two years now.   He no longer knows who my mom is and can’t form a sentence.  I still visit him when I’m home for holidays because he’s my dad, I love him, and even though it pains me, I want to see his face.  But the brilliant man with the razor-sharp wit who I knew as Dad has been fading away for almost a decade, as I recounted in a post about Thanksgiving a couple of years ago.  That was the last time he was able to carry on a conversation (sort of) with me.

The brain is made largely of cholesterol, with much of it in the synapses that transmit nerve impulses.  My dad beat his cholesterol down with Lipitor for 20 years.   I can’t prove Lipitor caused the damage to his brain, but while he was still in his 60s, he experienced a couple of day-long episodes of profound confusion remarkably similar to those described by Dr. Duane Graveline in his book Lipitor: Thief of Memory.

Dad started driving erratically in his late 60s, stopped reading books (he’d always been a voracious reader) and became befuddled over simple tasks like using a TV remote.  I took him to see the movie “W” nearly four years ago, and in talking about it afterwards, I realized Dad thought there had been three Presidents from the Bush family.  I asked him if he remembered a guy named Bill Clinton.  He didn’t.

By the time I read Dr. Graveline’s work and made the connection, my dad was in rapid decline.  My mom stopped giving him the Lipitor, which caused my dad’s cardiologist to go berserk and try bullying her.  After all, he no doubt read in medical journals how rare the side effects are for these wonderful drugs.  I offered to fly home from California and shove several pages of research up his colon, but my mom declined.  In one of his rare lucid moments at the time, Dad told my mom he’d rather die of a heart attack than succumb slowly to Alzheimer’s.

When my dad first became confused while still in his 60s, none of the doctors who examined him had a clue what was going on.  Nobody suggested the Lipitor he was taking may be part of the problem.  Perhaps if the FDA had required warnings back then about possible memory loss, someone would have made the connection.  Maybe that would have made a difference, maybe not.  We’ll never know.

Now we’ll see if those warnings have any effect on the statin-pushing doctors.

Share

172 thoughts on “New Statin Warnings

  1. Alex

    My mum is taking statins and has type 2 diabetes. Should she talk to the docter about stopping the statins? Also is flax seed or quinoa porridge suitable for diabetics?

    Thanks alot

    Best way to test your reaction to a particular food is to use a glucose meter an hour after eating.

    Your mom’s doctor will probably tell her to keep taking the statins. I’d order her a copy of Dr. Malcolm Kendrick’s book “The Great Cholesterol Con” and suggest she read it.

    Reply
  2. Lisa

    I had to laugh reading your article. As someone in the medical marketing field I know all too well how you can put a spin on a trial. And it is a double edged sword. There is good research and good drugs that have resulted from the research process. But it’s still a business and you have to get the money to continue doing the research somehow, and that has to be by driving business. No one is going to pay the pharma companies to do research, they have to generate the money on their own.

    Reply
  3. Patch 14

    Today, I visited my Dr to discuss my recent chloresterol results. We have a different measurement system here in the UK so my results may confuse you but suffice to say they are within the higher range of normal. My blood pressure was 98/60, my BMI 24 and I am NOT diabetic. My Dr has asked me to lose 6 kilos, go to WeightWatchers to lose them over 3 months, eat only red meat on “festive days” (Xmas and Easter) and why did she tell me all this? Because “I must get my levels down as both the LDL levels (slightly above normal) and HDL levels (twice normal, and I thought that was good!!!) must come down, as the TOTAL AMOUNT WAS TOO HIGH. In her opinion!!!!!!! She also added “I don’t think we need to think about statins at the moment”!!!!!!
    I don’t intend to think about them at all!!!!!!!!!

    I agree with Dr Malcolm Kendrick’s book “The Great Chloresterol Con” and am now re-reading it. I already eat a dairy free and yeast free diet and have done for the past 12 months, because of intolerances and feel the best I have done in years. I take Omega-3, a vitamin/mineral supplement, Calcium with Vit.D, and Glucosamine with Chlodroitin (for the old joints’ I’m no spring chicken!) and feel great!!

    Reply
  4. Patch 14

    Today, I visited my Dr to discuss my recent chloresterol results. We have a different measurement system here in the UK so my results may confuse you but suffice to say they are within the higher range of normal. My blood pressure was 98/60, my BMI 24 and I am NOT diabetic. My Dr has asked me to lose 6 kilos, go to WeightWatchers to lose them over 3 months, eat only red meat on “festive days” (Xmas and Easter) and why did she tell me all this? Because “I must get my levels down as both the LDL levels (slightly above normal) and HDL levels (twice normal, and I thought that was good!!!) must come down, as the TOTAL AMOUNT WAS TOO HIGH. In her opinion!!!!!!! She also added “I don’t think we need to think about statins at the moment”!!!!!!
    I don’t intend to think about them at all!!!!!!!!!

    I agree with Dr Malcolm Kendrick’s book “The Great Chloresterol Con” and am now re-reading it. I already eat a dairy free and yeast free diet and have done for the past 12 months, because of intolerances and feel the best I have done in years. I take Omega-3, a vitamin/mineral supplement, Calcium with Vit.D, and Glucosamine with Chlodroitin (for the old joints’ I’m no spring chicken!) and feel great!!

    Reply
  5. Rhonda Cowsert

    I never knew about the connection between diabetes and statins. UGH!!

    My blood sugars had always been normal but my cholesterol was up a bit a couple of years ago when I visited the doctor. At the time I hadn’t watched FatHead and was toeing the party line on low fat/low calorie diets. When the doctor nearly had a stroke at my cholesterol numbers (249) I hung my head in shame, accepted the script for Lipitor and promised to eat better and exercise more.

    I took the statin for about a week and it was the worst week of my life. Forget moving more, I could barely move off of the sofa. At first I thought I had the flu – my whole body ached, my muscles were weak – just walking the 10 feet from the sofa to the bathroom required a 45 minute resting period to recover.

    Eventually I began to fear there was something more wrong than just a virus. Everyday the fatigue, aches and pains, listlessness, etc. became worse but there was no fever, no other symptoms that would indicate illness. Finally I started to wonder if I was having a weird reaction to my new medication – a quick Google search told me that I probably was having a reaction to my new medication and that it was definitely NOT an uncommon occurrence.

    I stopped taking it immediately and within 24 hours was starting to feel a bit more human but it took another week or so to fully get back on my feet. I’m SO glad that I didn’t keep on with it – hard telling how badly that would have gone. Directly after this experience was when my blood sugars started coming back in the ‘pre-diabetic’ range. Not saying that it’s necessarily the cause because we definitely have a history of it in my family but now I’m wondering if it isn’t the catalyst that pushed me over the edge.

    Your body was telling you something: it needs cholesterol.

    Reply
  6. Rhonda Cowsert

    I never knew about the connection between diabetes and statins. UGH!!

    My blood sugars had always been normal but my cholesterol was up a bit a couple of years ago when I visited the doctor. At the time I hadn’t watched FatHead and was toeing the party line on low fat/low calorie diets. When the doctor nearly had a stroke at my cholesterol numbers (249) I hung my head in shame, accepted the script for Lipitor and promised to eat better and exercise more.

    I took the statin for about a week and it was the worst week of my life. Forget moving more, I could barely move off of the sofa. At first I thought I had the flu – my whole body ached, my muscles were weak – just walking the 10 feet from the sofa to the bathroom required a 45 minute resting period to recover.

    Eventually I began to fear there was something more wrong than just a virus. Everyday the fatigue, aches and pains, listlessness, etc. became worse but there was no fever, no other symptoms that would indicate illness. Finally I started to wonder if I was having a weird reaction to my new medication – a quick Google search told me that I probably was having a reaction to my new medication and that it was definitely NOT an uncommon occurrence.

    I stopped taking it immediately and within 24 hours was starting to feel a bit more human but it took another week or so to fully get back on my feet. I’m SO glad that I didn’t keep on with it – hard telling how badly that would have gone. Directly after this experience was when my blood sugars started coming back in the ‘pre-diabetic’ range. Not saying that it’s necessarily the cause because we definitely have a history of it in my family but now I’m wondering if it isn’t the catalyst that pushed me over the edge.

    Your body was telling you something: it needs cholesterol.

    Reply
  7. Howard

    Hey, Tom! I ran across an article at Less Wrong (http://lesswrong.com/lw/ajj/how_to_fix_science/) which goes into various reasons why “Science is Broken.” Some of the ideas are things you talked about in your “Science For Smart People.” He identifies 3 breakage points:

    1) Publication bias
    2) Experimenter bias
    3) Bad statistics

    It’s a pretty interesting read.

    Good article.

    Reply
  8. Jane

    My daughter sent me this link this week: http://www.laleva.org/eng/2012/03/world_renown_heart_surgeon_speaks_out_on_what_really_causes_heart_disease.html; this daughter has been reluctant to give up her low-fat ways, and she surprised herself by sending this to me. Maybe it’s a start. I was on Lipitor for 5 years; developed Type II diabetes, but had terrible memory issue along with anger management – which is also a side-effect. Against all advice I went off them almost 5 years ago, and I know I’m much the better for it. Still struggling with the diabetes, but that will be a lifetime thing.

    Let’s hope your daughter sees the light before she ends up a diabetic as well.

    Reply
  9. Howard

    Hey, Tom! I ran across an article at Less Wrong (http://lesswrong.com/lw/ajj/how_to_fix_science/) which goes into various reasons why “Science is Broken.” Some of the ideas are things you talked about in your “Science For Smart People.” He identifies 3 breakage points:

    1) Publication bias
    2) Experimenter bias
    3) Bad statistics

    It’s a pretty interesting read.

    Good article.

    Reply
  10. Jane

    My daughter sent me this link this week: http://www.laleva.org/eng/2012/03/world_renown_heart_surgeon_speaks_out_on_what_really_causes_heart_disease.html; this daughter has been reluctant to give up her low-fat ways, and she surprised herself by sending this to me. Maybe it’s a start. I was on Lipitor for 5 years; developed Type II diabetes, but had terrible memory issue along with anger management – which is also a side-effect. Against all advice I went off them almost 5 years ago, and I know I’m much the better for it. Still struggling with the diabetes, but that will be a lifetime thing.

    Let’s hope your daughter sees the light before she ends up a diabetic as well.

    Reply
  11. Stephen Brand, CPT, SFN, SSF

    Tom, so sorry about your Dad. Sometimes I beat myself up with “If only I had known then…”. My daughter was “diagnosed” with bipolar disorder and has been on medications since she was 9 years old; she is now 20. Mental illness/emotional instability runs in our family. Now I’m thinking maybe the wheat has played a part in that. I’ve tried to get her to quit her meds (slowly with the help of her doctor) but she’s afraid. I’m concerned about her long-term brain-chemistry health as well as the health of her liver. And the fact that someday the money to pay hundreds of dollars a month for these drugs will not be there. If I knew then what I know now I would never have agreed to let her take drugs and now she is an adult and I have no say. I’m so angry I could spit s***. One good thing: I was able to convince my wife not to take the statin her doc prescribed. Keep up the good work.

    I’m sorry to hear about your daughter. You might find the book “Anatomy of an Epidemic” enlightening.

    Reply
  12. Stephen Brand, CPT, SFN, SSF

    Tom, so sorry about your Dad. Sometimes I beat myself up with “If only I had known then…”. My daughter was “diagnosed” with bipolar disorder and has been on medications since she was 9 years old; she is now 20. Mental illness/emotional instability runs in our family. Now I’m thinking maybe the wheat has played a part in that. I’ve tried to get her to quit her meds (slowly with the help of her doctor) but she’s afraid. I’m concerned about her long-term brain-chemistry health as well as the health of her liver. And the fact that someday the money to pay hundreds of dollars a month for these drugs will not be there. If I knew then what I know now I would never have agreed to let her take drugs and now she is an adult and I have no say. I’m so angry I could spit s***. One good thing: I was able to convince my wife not to take the statin her doc prescribed. Keep up the good work.

    I’m sorry to hear about your daughter. You might find the book “Anatomy of an Epidemic” enlightening.

    Reply
  13. Thomas

    Tom you are killing me dude. I think you are doing a real disservice to all of us. You see, we live in this wonderful cozy little world where we can let other people do our thinking for us and never have to examine evidence and think critically about what we believe. If everyone started thinking for themselves like you propose we might end up “following the money” on a lot of things and if we do that we might not trust people in thousand dollar suits and lab coats to know what is best for us.

    I am not sure the world is ready for free people that actually think for themselves. They might start making decisions based on their own interpretation of the evidence and end up being responsible for their own outcomes. Pure chaos man. I for one am not willing to stand by and let this not happen.

    I apologize for any anarchy that may result.

    Reply
  14. Thomas

    Tom you are killing me dude. I think you are doing a real disservice to all of us. You see, we live in this wonderful cozy little world where we can let other people do our thinking for us and never have to examine evidence and think critically about what we believe. If everyone started thinking for themselves like you propose we might end up “following the money” on a lot of things and if we do that we might not trust people in thousand dollar suits and lab coats to know what is best for us.

    I am not sure the world is ready for free people that actually think for themselves. They might start making decisions based on their own interpretation of the evidence and end up being responsible for their own outcomes. Pure chaos man. I for one am not willing to stand by and let this not happen.

    I apologize for any anarchy that may result.

    Reply
  15. Kim

    I know I’m late to the party here, but I just wanted to chime in. My father is another casualty of statins. He has Type 2 diabetes and was on statins for years. He suffered cognitive decline, muscle pain/weakness and finally statin induced cardiomyopathy. This resulted in open heart surgery to replace aortic valve and triple bypass. Yep, that’s right; statins don’t prevent plaque buildup in the arteries. So my father is an example of the stunning failure of statin drugs to prevent heart disease. He’s 81 now (we’re all shocked) but can’t take care of himself. He quit the statins when he had surgery 2 1/2 yrs. ago but the damage was permanent.


    Never too late to join this party. Sorry about your father.

    Reply
  16. Kim

    I know I’m late to the party here, but I just wanted to chime in. My father is another casualty of statins. He has Type 2 diabetes and was on statins for years. He suffered cognitive decline, muscle pain/weakness and finally statin induced cardiomyopathy. This resulted in open heart surgery to replace aortic valve and triple bypass. Yep, that’s right; statins don’t prevent plaque buildup in the arteries. So my father is an example of the stunning failure of statin drugs to prevent heart disease. He’s 81 now (we’re all shocked) but can’t take care of himself. He quit the statins when he had surgery 2 1/2 yrs. ago but the damage was permanent.


    Never too late to join this party. Sorry about your father.

    Reply
  17. David B.

    Tom,

    I’m a long-time lurker, first time commenter. I loved the movie, and I’m also a programmer, so I feel like I really _get_ you, haha.

    My wife is 33 and had an ischemic stroke in November (of 2011). All tests give no indication as to why she may have had a stroke at such a young age, but did reveal a PFO (http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002102/) which could contribute, but not necessarily cause the stroke. She also has some other minor heart defects.

    Some docs want to close the PFO, though there is little data to support this will reduce the risk of recurrent stroke.

    Almost ALL doctors she has seen wants to put her on a statin, likely because of this study: http://www.webmd.com/stroke/news/20110801/statins-lower-recurrent-stroke-risk-young-adults

    It doesn’t help that she just got bloodwork done, with these results:
    HDL: 48
    Cholesterol: 219 (High)
    Triglycerides: 82
    Chol/HDL ratio: 4.6 (High)
    LDL (Calculated): 155 (High)

    So, the docs will now be insisting on the statin. She has been eating pretty well the past few years, but we are transitioning to a more strict paleo diet and are starting strength training…. Needless to say, I’m torn on the issue of the statin. Especially since the above study seems to indicate a LARGE reduction in risk of recurrent stroke.

    Any ideas on this?

    I can only tell you what I’d do. I wouldn’t take a statin. Too many possible side effects. The study appears to a small observational study, and I personally wouldn’t make much of it.

    Reply
  18. David B.

    Tom,

    I’m a long-time lurker, first time commenter. I loved the movie, and I’m also a programmer, so I feel like I really _get_ you, haha.

    My wife is 33 and had an ischemic stroke in November (of 2011). All tests give no indication as to why she may have had a stroke at such a young age, but did reveal a PFO (http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002102/) which could contribute, but not necessarily cause the stroke. She also has some other minor heart defects.

    Some docs want to close the PFO, though there is little data to support this will reduce the risk of recurrent stroke.

    Almost ALL doctors she has seen wants to put her on a statin, likely because of this study: http://www.webmd.com/stroke/news/20110801/statins-lower-recurrent-stroke-risk-young-adults

    It doesn’t help that she just got bloodwork done, with these results:
    HDL: 48
    Cholesterol: 219 (High)
    Triglycerides: 82
    Chol/HDL ratio: 4.6 (High)
    LDL (Calculated): 155 (High)

    So, the docs will now be insisting on the statin. She has been eating pretty well the past few years, but we are transitioning to a more strict paleo diet and are starting strength training…. Needless to say, I’m torn on the issue of the statin. Especially since the above study seems to indicate a LARGE reduction in risk of recurrent stroke.

    Any ideas on this?

    I can only tell you what I’d do. I wouldn’t take a statin. Too many possible side effects. The study appears to a small observational study, and I personally wouldn’t make much of it.

    Reply
  19. Joanne

    I read this week that doctors get $100 from the pharmas for each person put onto statins. I refuse to get on them. I was on simvastatin for 7 months and I got so sick I could hardly move. My stomach hurt so bad that I could function. I stopped taking them and will never take another statin.

    Reply
  20. Joanne

    Also, I went to a health food store and was told by one of the men in the vitamin department that I should take red yeast rice as it is the stuff that statins are made from before they “put the poisons into them.” That made my heart feel great to know that I had been taking poisons for 7 months. No wonder my body hurt so bad. I stopped taking the simvastatin and take only the red yeast rice and feel great. Have my energy back, etc. It’s interesting that when I emailed my doctor that my stomach was killing me and I had no energy, he changed me to another statin, and that’s when I switched over to the red yeast rice.

    I wouldn’t even recommend the red yeast rice. The idea that you need to beat down your cholesterol to be healthy simply isn’t true.

    Reply
  21. Dr. Sydney Bush

    People should try asking editors of journals why my offers to trial statins using CardioRetinometry(R) to determine an ‘end point’ for treatment, i.e. to evaluate reduction
    of blockages in the retinal microvasculature, a predictive surrogate indicator of coronary artery disease, probably more accurate and a thousand times safer than X-Ray angiography, are always rejected. After all, Baycol was withdrawn with damages paid, and the case is mounting for a class action with the reporting of many cases of cognitive impairment to name only one. If studies show that vitamin E is compromised by statins a very strong case would exist for the thousands who have complained of muscle weakness and pain. Reduction of vitamin E also, would prevent claimed life extension despite 30 years of trying. Inhibition of Co-Enzyme Q10 would additionally contribute to early death and the finding that you have to have a first heart attack before any claim can be made for prevention – and then only against having a second! Somebody might even offer to fund a study for me to evaluate these things?

    Reply
  22. Dr. Sydney Bush

    People should try asking editors of journals why my offers to trial statins using CardioRetinometry(R) to determine an ‘end point’ for treatment, i.e. to evaluate reduction
    of blockages in the retinal microvasculature, a predictive surrogate indicator of coronary artery disease, probably more accurate and a thousand times safer than X-Ray angiography, are always rejected. After all, Baycol was withdrawn with damages paid, and the case is mounting for a class action with the reporting of many cases of cognitive impairment to name only one. If studies show that vitamin E is compromised by statins a very strong case would exist for the thousands who have complained of muscle weakness and pain. Reduction of vitamin E also, would prevent claimed life extension despite 30 years of trying. Inhibition of Co-Enzyme Q10 would additionally contribute to early death and the finding that you have to have a first heart attack before any claim can be made for prevention – and then only against having a second! Somebody might even offer to fund a study for me to evaluate these things?

    Reply

Leave a Reply

Your email address will not be published.