The legacy effects of statins: a role for RxISK
Editorial Note: This chilling account of the effects of statin drugs brings out a key role for reporters to RxISK.org – we need good data on how long the after-effects of drug treatment can last. This data is rarely collected but is of critical importance when it comes to insurance and disability assessments.
A statin is a lipid-lowering agent and although the mechanism is not fully understood or agreed upon by the medical professionals – statins do appear to lower cholesterol. However is the lowering of cholesterol beneficial in reducing heart mortality and what are some of the consequences of lowering cholesterol? This is my personal experience and I do not wish to contradict or undermine those people who tirelessly work towards lowering cardiovascular disease.
“What has happened to you was rare, a 1-million chance
of this type of reaction.” said Auckland doctor in 2002.
My husband Brian and I live in Auckland, New Zealand. Brian was an active person who enjoyed walking, swimming, writing and watching sport. He had solid computer skills in his job with a major airline and was responsible for paying about 700 staff. Brian was a good communicator and was extremely thorough and analytical in his work. He was able to do complex equations in his head and prided himself on accuracy. Honesty and confidentially were key to this job. He also contributed short stories to books held in the National Library and enjoyed looking forward to planned holidays.
That was until a weekend in June 2002 when our lives changed forever. On May 1st 2002 Brian started taking a statin prescribed by a cardiologist based on Brian’s family history and not his health. The cardiologist agreed he was physically fit and did not otherwise meet the criteria for a statin. No blood tests were taken.
Several weeks later Brian became seriously ill with a life threatening event we now know is called rhabdomyolysis which means his muscle tissue melted. This caused acute renal failure. Our GP did not recognize the symptoms which included severe pain in the right flank, frequent vomiting, nausea, no urine output, confusion and weakness.
The GP did not feel it was necessary to do blood tests until pressured by me to do so. When the test results showed Brian had renal failure the doctor’s response was to get Brian to drink a further 4 litres of water. This exacerbated the already dangerous situation. It was 5 days after the initial onset of these symptoms before Brian was hospitalized.
Caused by Simvastatin
Once hospitalised at North Shore Hospital the doctors examined Brian and confirmed the renal failure due to the statin. Neither of us understood most of what was said but were grateful for their help. Brian was transferred to the renal unit at Auckland Hospital and started dialysis. This was now 7 days after the onset of symptoms.
During the course of his treatment both in the hospital and as an outpatient, Brian and I mentioned his weakness, pain, nausea, tingling sensations in many of his muscles, fatigue and frequency in urinating once his kidneys started working again. The list also included urinary incontinence, impotence, confusion, tiredness, widespread discomfort, nightmares, anxiety, thumping headaches and an inability to seize and understand facts.
While he was on dialysis Brian had what we were told 3 years later was a stroke. Neurologists have told us this was due to the extreme stress his body was under in addition to the toxicity from the statin.
Reporting the Problem
Mandatory reporting of adverse reactions is not required in NZ, so I gave the information to the Centre for Adverse Reactions in Dunedin and it was also recorded at the WHO database by Merck Sharp and Dome.
Brian remained on dialysis for some time and eventually his kidney function returned but he remained very ill and was unable to do much without assistance.
Getting Compensated
In New Zealand we have a compulsory accident cover. It is called the Accident Compensation Corporation. ACC is the sole and compulsory provider of accident insurance for all work and non-work injuries. The ACC Scheme is administered on a no-fault basis, so that anyone, regardless of the way in which they incurred an injury, is eligible for coverage under the Scheme. Due to the Scheme’s no-fault basis, people who have suffered personal injury do not have the right to sue an at-fault party, except for exemplary damages.
ACC accepted our claim that Brian had a medical misadventure and he was assured by his case manager at ACC that any future treatment relating to his injury – for the duration of his life would be covered by ACC. This was in 2002.
ACC provided support with speech language therapists, physiotherapists, psychologists and ongoing treatment from muscular skeletal specialists.
When Brian did not make a full recovery he was retired from his employment and I left my full time job to assisted Brian with day to day tasks like showering and getting dressed. Making decisions were now often difficult for him, he was easily confused about what was required of him and exhausted much of the day. Logging in to a computer was much too hard for him and driving was initially impossible. Brian had become very vulnerable and emotional often weeping with fear and frustration at his inability to move on with his life.
I read as much as I could about rhabdomyolysis and muscle damage. We changed our diet to include far more vegetables, eliminated processed foods and reduced carbohydrates and under medical advice from overseas doctors I included – CoQ10, Omega 3, and magnesium.
I was also really concerned to find thousands of others world wide had been damaged by statins. I had information from the Centre of Adverse Reactions in Dunedin in 2010 which said 11 people in NZ have died from simvastatin and there are over 30 reports of rhabdomyolysis in their database. I didn’t ask about other statins. It is my belief that ACC and in general, the medical profession and pharmaceutical companies would prefer these statistics were not made public.
Compensation Quicksands
The first eight years after the adverse reaction were really hard for Brian and he has shown courage and determination to be the best he can. Many of the original symptoms from 2002 became more manageable but he still suffers from ongoing pain and is limited in his capacity to function fully in society. Until 2009 ACC was very supportive so we could concentrate on Brian’s rehabilitation.
However since 2009, ACC has continued to strive to ‘prove’ he didn’t have an adverse reaction to the statin or the symptoms from the statin injury are spent or most frustratingly that the symptoms are all age related or pre-existed 2002.
Over the next two years he was sent for assessment after assessment, in total around 15. Each assessment leaves him exhausted and traumatised. He was compelled to attend each appointment in order to preserve his entitlements with the ACC. Brian battled on and almost every specialist agreed with the original diagnosis. However it took just one report challenging the original diagnosis to determine that the effects of the injury were now spent. As a consequence Brian has now had his entitlements suspended.
This has directly impacted on our relationship and health. At times, both of us have felt we could not face one more day of this additional pressure. Brian’s nightmares and anxiety have become more regular and his speech and confidence in communicating with people has deteriorated as he has to endure the retelling of details of the original injury and subsequent illness to medical assessors contracted by ACC.
In 2012 we opted for Brian to have a muscle biopsy to ‘show’ he had long standing damage from the statin. The results did not show any mitochondrial damage but did show cell hypertrophy. The muscular skeletal specialist has explained that essentially the muscle cells which survived the rhabdomyolysis became super big and have contributed to the body wide discomfort.
Brian has also had a blood test to see if he had any genes that could predispose him to statin-induced myotoxicity. But he was negative for these tests.
Was it Needed?
To our knowledge Brian had no pre-existing health disorders, he didn’t have diabetes or any cardiovascular disease. But his father, mother and brother had all had heart attacks. So it is reasonable to assume that taking a statin to lower cholesterol would be just the thing for Brian. This is what the advertisements say. This is what the doctors say – at least the ones who haven’t read the impartial reports about cardiovascular disease and mortality.
It is strange then to think that Brian’s mother was on a statin but still had a heart attack.
His younger brother was on a statin for years and developed a heart problem and later had a heart attack and triple bypass and he is still on high doses of a statin. He has also developed diabetes.
Does Cholesterol need to be Lowered?
Maybe lowering cholesterol isn’t the answer. Many well known doctors and researchers are bold enough to query the statistics provided by the pharmaceutical companies. And to their credit many doctors we have dealt with over the last 11 years have been very supportive and for that we would like to thank them.
Could it be that inflammation or other factors cause atherosclerosis? Is animal fat relevant? Does a diet full of processed foods affect our heart? Would we be better with a diet rich in olive oil and fish? Physicians, scientists and science writers are debating these issues. Having a debate about it is good. It’s a start. Our goal should be to reduce disease but not at the risk of damaging other parts of the body. Nobody should have to go through what we go through every day.
Persisting and unresolved damage from the statin injury has remained a problem for Brian, but we must also endure ongoing legal battles with ACC to ensure his Claimant Rights are being met.
There are still too many doctors and health professionals who are not willing to look at drug side effects, overall risk versus benefit and most importantly the need to remember the Hippocratic Oath: ‘I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.’
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Make your voice heard!
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Thanks so much for this incredible yet all too familiar story of ongoing statin harm. We all hope that these stories of lived experiences will push the research, medical and insurance establishment to reverse their embrace of the official story that “so safe they should be in the drinking water.” In the mean time, peer support of the kind offered on this site is essential.
We are all tired of hearing that our harms are rare…that with discontinuation, our impairments will just simply go away.
Recently, a Cochrane Review (update 2013) of statins for primary prevention stated that “the totality of evidence now supports statins for primary prevention” finding little harm and great benefit for men and women based almost entirely on data coming from commercially sponsored trials.
This claim to the “totality of evidence” is a chilling reminder of what we are up against. Even people, presumably of good will, can be trapped inside a way of thinking that excludes everything but the clinical trial as evidence. This narrow vision can persist despite a mountain of research about statin-associated muscle, cognitive, diabetes, kidney problems and birth defects which rarely show up in carefully selected and unrepresentative clinical trial populations.
The RXISK site provides an important antidote to the tunnel vision of “totality of evidence” and meaningful support for patient safety.
My husband, now 68, took statins for 8 years following CABGx4 at age 52. His father passed at age 63 (possibly due to a heart attack) so going forward we were more aware of any family history that would predispose him to a similar fate. My husband was a “runner” and when it seemed to take more effort to maintain his regime, we became concerned and made an appointment with a cardiologist. A stress test indicated a blockage know as the “widow maker”… bypass surgery was immediately scheduled. Either your husband has this surgery or “he will die”… not much of an option there… post op medications were statins and blood pressure drugs.
He was otherwise a very active, healthy male, both physically and mentally. After bypass surgery he could no longer jog/run due to muscle pain which was always present, only to be told by his doctors that the benefit of statins far outweighed any discomfort he was experiencing. He also experienced visual disturbances, erectile dysfunction, unexplained anger, insomnia and towards the latter part of the 8 years on statins (1st Zocor, then Lipitor) his memory and executive function were diminishing. All of these his doctors said were “age related”…
I discovered a link between Lipitor and memory loss (and other statin side effects) from research by Dr Duane Graveline, his first book, “Lipitor – Thief of Memory and the Misguided War on Cholesterol”. There was absolutely no support from our doctors with information that statins could be the culprit. We decided on our own to stop statins, but what to do next? There was little or no information available at that time to help guide us.
We were referred to a neurologist. PET scan and MRI were normal. Neuro-psych testing indicated early stages of Alzheimer’s. It was recommended that he start taking Aricept and resume taking Lipitor. We said NO to both.
My husband’s statin side effects started to improve, especially memory and muscle pain after stopping statins, but not for long. His executive function was hampering everyday activities that AGAIN, doctors said was due to aging.
I’ve researched extensively for the past 10 years in an effort to help my husband recover, but his health has steadily declined to the point that now he is completely bedridden, with what I feel is mitochondrial damage from statins, presenting as dementia and Parkinson’s. He also experienced a grand mal seizure in Aug, 2009.
We were receiving “hospice at home” for 1 year and 4 months, but just discharged due to “there’s been no change in his CONDITION for the past 2 months”, an ongoing requirement to stay in the program. Friends and family will help until his condition changes…
I mange a support group for those experiencing statin side effects, host a website and have a presence on Facebook. My goal is to provide information so that people can make an “informed” decision to either take or not take a statin drug.
Statins are literally pushed on almost every person that enters a doctors office and when side effects occur, reporting is almost non-existent, they are usually switched to another statin until the patient finally says, “no more”!
Stopping a statin does not always resolve side effects and most doctors are either not willing for their patients to stop or know how to treat unresolved side effects.
The ironic “twist” is that “sugar” (and simple carbs) is the primary culprit in one developing heart disease and NOT by consuming good healthy saturated fats and cholesterol. “People” (involvement of) are the only way of holding both the food industry and the drug companies accountable for misinformation that’s been repeatedly regurgitated for eons… That eating fat and cholesterol “clogs our arteries”… absolute hog wash! Another theory is “bacterial” infections as one of the causes of heart disease.
Do your research and take control of your own health.
I also believe that there are members of the medical profession who would prefer it if we remained reticent about adverse effects of medicines prescribed to us.
I don’t really understand why I have to be honest .
Following my own experience of a significant side effect – when I was on Enbrel- I mentioned it to the doctor/consultant who prescribed it to me and was met with an indignant reply that ‘alot of people are given this drug without any side effects like the one you had’
This left me feeling a bit odd- as if I had dared to reduce the importance of her medicine!
I really feel for Brian and his wife. I know all to well the frustration and sheer exhaustion that comes with fighting our Accident Compensation Corporation. My case manager has been excellent, but she is but one cog in the wheels of bureaucracy. I tend to agree that ACC and CARM do not seem to be doing their part in accident prevention by making such adverse events more widely known among the front line prescribers, GPs. It is they who often prescribe in ignorance of emerging adverse event data, they who so often feel the brunt of patients’ and families’ anger when things so seriously wrong. I’m waiting for the day (and I suspect it’s not too far away) when my entitlements are suspended, despite my multple and ongoing neurological impairments. The frequent assessments, having to pore over every detail of one’s condition and clinical history, are exhausting and often demeaning. There seems to be a (publicly) unwritten rule at ACC that after three years, you’re on your own. I live in constant fear of that day.
Further to what I previously said – I don’t believe I have ever been angry with my GP, who incidentally did warn me of the power of this particular drug – Enbrel(Entanercept)- however it was when I remarked to my consultant who prescribed it to me initially – that she was very fast to ‘side step’ any further conversation about my side effect – but also very fast to remark how she hadn’t experienced any side effects like mine with any of her other patients-
this left me feeling as if she was almost afraid of acknowledging that this drug could cause something major like I had experienced.
I understand how difficult it must be in getting the appropriate bodies, as in the case above, to ‘back them’ when needed.
Dear Gillian — Well it looks like Enbrel is the Number One Most Complained-of Drug according to FDA figures for 2004-2012! 143,696 reports. So you can’t be that much of an oddball. The Number Two drug is Enbrel’s close competitor and chemical cousin, Humira. Come to think of it, three of the top five drugs on that list are “tumor necrosis factor inhibitors.”
These are incredibly profitable drugs — they cost from $1500 to $2500 per month in the US. I know that Abbott Labs has just about bet the future of its whole pharmaceutical division on Humira. So the pressure to use them for less-drastic physical conditions, where the risks may outweigh the benefits, is growing. I just read a big article on a commercial health-info website which said the modern trend was to use them as soon as possible for “moderate” and “newly-diagnosed” rheumatoid arthritis. And Humira has sponsored radio ads, urging folks with back pain to go get checked for Ankylosing Spondylitis.
So while I don’t yet know anyone taking this stuff, I figure it’s coming soon to a clinic near me …
Simvastatin is the drug that I took until I couldn’t walk at all. After being off the drug, I can walk very slowly but with much pain. I was also put on the drug because of family history. This past summer I was in for several tests including angioplasty and it showed no clogging of the arteries at all but the damage to my legs and upper arms is permanent. I warn everyone I know that takes statins to beware.
I was a 29 year old Critical Care Registered Nurse, when I agreed to begin taking Lipitor…I had high cholesterol since I had a physical exam while in nursing school 10 years before, and probably my whole life. As an RN, I “knew” everything there was to know about these drugs, or so I thought. until 3 and 1/2 years later, I fell deathly ill, profound headaches and fatigue which kept me in bed up to 17 hours/day. and when I was awake, was extremely lethargic, disoriented, and confused. This occurred periodically for about 8 weeks. Upon exam in the Emergency room on 2 occasions, where I was released both times with a diagnosis of “migraine”…sorry, never had a headache in my life before this…my wife demanded they do an MRI, which was declined. When we got home the second visit, my wife called my doc, and requested an MRI scan, to which he agreed…which found multiple scattered lesions through the white and gray mater of my brain. Initial impression, was Multiple Sclerosis…I followed up with an MS specialist at the University hospital, who told me that they did not think I had MS, but they could not place a definitive diagnosis on my problems. I was to recheck there in 6 weeks. Over the course of the next few weeks, my symptoms worsened. My wife found me in the middle of the night, digging thru the kitchen garbage, and when she asked, I told her I was looking for some milk. On another occasion, she found me walking up the middle of the street in my underwear. When she approached me, I had no idea who she was, who I was nor what I was doing. That morning, she called the MS specialist, who instructed her to bring me to the ER at the University hospital, where he would meet us. Upon arrival there a few hours later, I had become completely incoherent…unable to speak coherently, nor walk without assistance. I failed a mini mental exam, and was admitted and spent the next 28 days. I underwent MRI scans, EMG, Brain and Muscle Biopsies and dozens of lab tests. The most remarkable, the Brain Biopsy revealed Neuronal Apoptosis, as well as Mitochondrial DNA mutations as evidenced by Light and Electron Microscopy. The mitochondria appeared similar to a condition called MELAS (Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke Like Episodes. Within a few days, I was evaluated by a visiting professor, who suggested a Mitochondrial Cocktail (Essentially 12 vitamins, Amino Acids and CoEnzyme Q10) When I began this cocktail, my condition began to improve to the point they stopped searching for a nursing home, and send me home with aggressive Physical, Occupational and Speech Therapies. Which I continued for several months, until I reached a point of Maximal improvement, which was far less than my pre illness state, but far better than where I was when I was in the hospital. Several months later, I saw Dr Beatrice Golomb, on Good Morning America, being interviewed by Diane Sawyer. She was talking about a “Statin Effects Study” which she was doing, and my wife pleaded with me to enroll, which I did, even though I knew Lipitor had nothing to do with my illness, nor disability. Several months later, I received a phone call from Dr Golomb, who informed me that my case was among several others in her study with similar effects, and that she referred our cases to Dr Doug Wallace, reportedly on the the worlds foremost Mitochondrial Disease Experts, From UC Irvine, who opined that it was his opinion, that Lipitor was the likely causal contributor to the Mitochondrial DNA mutations, as well as the holes that were seen in my brain. I WAS FLOORED!!! My illness began more than 10 years ago, in Oct 2002, and I remain unable to work, due to cognitive slowing, impaired memory, Constant muscle pain, Peripheral Neuropathy, Profound constant fatigue etc and so on…I find great comfort in the fact that there are physicians, such as Drs Steven Sinara, Duane Graveline, and Uffe Ravnskov, Russell Blaylock, Peter Langsjoen , Chris Nagy among other physicians who are willing to question this most absurd notion that Cholesterol causes heart disease…that statement is as laughable as saying Oxygen causes lung cancer…
Brian and I have been very moved by the comments which have been made by others who have witnessed or had a statin adverse reaction. On the days when we feel it is easier to give up the battle for acknowledgement we reflect on the many others who do not yet know what is causing their symptoms. So, I guess we will just keep writing letters and spreading the word around about people like yourself who have the determination to keep positive. Someone wrote to me recently and said I was too determined to be defeated by ACC or the pharmaceutical companies. The emotional cost is high but I think if I did and said nothing it would be worse. Our best wishes go out to you Christopher and all the others who have posted on RxISK. Heather
My mother was put onto simvastatin, a few years ago. She soon lost her ability to use her legs, to even stand up. We got her off of the statin, with doctor permission. We put her on a liquid CoQ10 supplement. Her leg muscles recovered enough that she was once again able to stand, and to walk short distances. Then she unfortunately decided the problem was cured, and stopped taking the CoQ10. Her legs reverted into uselessness, and her muscles atrophied into permanent uselessness. This was two years ago. She did not have a cholesterol problem – the simvastatin was prescribed under the theory it would prevent a heart attack.