A Near-Fatal Adverse Drug Reaction to a Cholesterol Lowering Medication: 

One Couple’s Story

 

By Heather Barker

 

 

May 1, 2002 was the day my life changed. At first the subtle changes seemed inconsequential and trivial, but somewhere in those few weeks between late May and June 2002, I noticed an undefinable change in odour when I was close to Brian. It wasn’t unpleasant at all and I didn’t even think to mention it to the doctors in the emergency room. That realisation came much later. My retelling of the events of the rapid onset of his pain accompanied by horrendous vomiting hasn’t altered much over the last eleven years, but my awareness about the complex nature of the body has increased so I can grasp more of the processes involved in acute kidney injury.

At this point I am going to add my disclaimer so you can choose to read on or stop before you read something which may challenge your current point of view.

 

Any medical comments made by me are intended to be of a general nature only and are not designed to give specific medical advice.  If you have a medical problem you should consult your own physician for advice specific to your own situation. When I thought Brian might die he made me promise to tell people about the dangers of making certain choices relating to medication. My mission has been to provide you the reader with a viewpoint. Please discuss your experiences with statin (cholesterol lowering) drugs with your family, friends and doctor. Don’t be put off by high handed comments about ‘safety’. Ultimately it is your decision.

 

I have written this essay for myself, family and friends. Anyone is welcome to use it as a reference.

 

If only. How many times have I said or thought that in the last decade? If only Brian didn’t have a family history of heart disease. If only he hadn’t asked to see a cardiologist. If only the cardiologist hadn’t given him a statin. If only I had taken him to the hospital myself on day one, instead of trusting that our doctor would know what was causing the problem.

 

The first few days listening to the gut wrenching, heaving spasms that tore through his body penetrated my soul. At the best of times I’ve got a shocking gag reflex and the mere sound of someone throwing up is enough to set me off too. When you look at the definition of vomiting in a medical dictionary it’s called emesis – the forceful expulsion of the contents of one’s stomach. Nothing could have ever prepared me for the relentless sound of the man I loved crouching on the toilet floor, shaking with pain and fear and dry retching. In the following weeks I discovered the severity of his excessive vomiting probably caused a hiatus hernia, and this might all have been avoided if only we had known the warning signs or if our doctor had acted faster instead of assuming it was a stomach bug.

Life Before the Statin

 

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 large company 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 – especially cruises.

Although Brian was physically fit with only mild hypertension and did not really meet the criteria for a statin, his cardiologist thought it was probably worthwhile to start him on simvastatin based on Brian’s family history only.

 

Cholesterol lowering medications are sold under many names but mostly have similar properties. They include Atorvastatin, Zocor, Lipex, Lovastatin, Mevacor, Lipitor, Fluvastatin, Lescol to name a few. Simvastatin is also included with Ezetimibe and many pharmaceutical companies produce and market a type of poly pill with multiple active pharmaceutical ingredients like statins.

 

As for Brian, other than cholesterol, no blood tests were taken before he started simvastatin to identify a baseline for kidney or liver function.  Several weeks after starting simvastatin he became seriously ill with a life threatening event called rhabdomyolysis, which means skeletal muscle tissue breaks down rapidly. He now had acute renal failure. To complicate matters our GP did not recognize the symptoms which included severe pain in the right flank, frequent vomiting, nausea, no urine output, confusion and weakness.  I have since discovered the main goal of treatment for acute kidney injury is to treat shock and preserve kidney function. The faster this occurs the better chance of a good outcome. Rhabdomyolysis associated acute kidney injury possibly accounts for roughly 5%–10% of cases of the disorder in intensive care units, dependent on the setting. There is also a likelihood of developing rhabdomyolysis in some crush injuries for instance after earthquakes or nontraumatic nonexertional injuries from toxic substances eg, drugs, infections, or electrolyte disorders maybe after a marathon.

 

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. Medical terminology can be very precise but terribly confusing. I  heard people talk about kidney failure but was unaware that renal failure was the same and when I was told Brian was to be transferred to the renal unit at Auckland Hospital and start dialysis I was bewildered. This was now seven 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, frequency in urinating and impotence. The list also included confusion, widespread discomfort, nightmares, anxiety, thumping headaches and an inability to seize and understand facts. His usually well controlled mild hypertension went through the roof causing consternation for his medical team.

While he was on dialysis Brian had probably had a stroke. We were only told this three years later. Neurologists have told us this was possibly due to the extreme stress his body was under in addition to the toxicity from the statin. At the time all the focus was on his kidneys, liver and heart health and other symptoms seemed secondary and less important.

Brian remained on dialysis for several weeks and eventually his renal function returned but he remained very ill. He was unable to do much without assistance for quite some time. 11 years have passed. Brian has made gains in his strength, even so we believe his health has now reached a plateau.

             Who needs to know when you have an adverse reaction to a medication?

There is no legal requirement for New Zealand doctors to report adverse reactions.  Needless to say I found this omission to be very frustrating so I gave the information to the Centre for Adverse Reactions in Dunedin and the event was also recorded at the World Health Organisation database by Merck Sharp and Dohme. Not being medically trained I used common language to explain things on the forms; for example: hematuria is the medical term for red blood cells in the urine – however I wrote blood in his urine. Nevertheless his World Health Organisation records describe a clear picture of someone who was seriously ill. Other countries have various methods for monitoring drug reactions.

An adverse reaction to a drug has been defined as any noxious or unintended reaction to a drug that is administered in standard dose.

 

The United Kingdom has The Yellow Card Scheme and is used to collect information from both health professionals and the general public on suspected side effects or Adverse Drug Reactions to a medicine.

The Australian Adverse Drug Reaction Reporting System includes complementary, Over The Counter sales, prescription medication or a vaccine.

It is my belief that all adverse reactions should be recorded accurately to ensure patient safety. It is an ongoing process and in many cases the only precise record available which has not been influenced by revenue.

A longitudinal study is research that involves repeated observations of the same variables over long periods of time – often many decades. Several large statin studies which are frequently quoted have involved plenty of observations; however the variables have been changed or pertinent pieces of information have been omitted.

Often longitudinal studies show unwanted outcomes only after many decades.

             Is anyone at fault?

In New Zealand we have a compulsory accident cover. It is called the Accident Compensation Corporation. ACC is the compulsory provider of accident insurance for all work and non-work injuries. The ACC scheme is administered on a no-fault basis, so  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. Doctors tell me this should be a good system as they don’t have to incur huge costs from insurance or litigation. Once I would have agreed with them.

The NZ government owned Accident Compensation Corporation (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.

Brian returned to part time work and when after three years he did not make a full recovery he was medically retired from his employment.

Making decisions was now often difficult for Brian. 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. Brian felt unable to meet his obligations and was distressed by his perceived deficits. He had heightened anxiety when unwelcome thoughts about hospital, doctors or dialysis entered his head. Even his sleep was disturbed by these uninvited images.

 

Unfortunately in 2009 Brian’s ACC file was transferred to the “Recover Independence” service.  Over the next three years Brian had  eighteen different assessments which, according to internal memos, appeared to be designed to ensure that Brian ACC payments were stopped. When Brian turned 65 years old (and was therefore entitled to the NZ government National Superannunation – a non-mean tested pension) we were informed he was no longer eligible for ACC.  This meant that ACC no longer pays any of the medical bills relating to his ongoing disability.

 

We are not alone

 

I read as much as I could about rhabdomyolysis and muscle damage. I talked to people around New Zealand, United Kingdom, United States of America and Australia or anywhere I could, to get answers. Often the answers prompted more questions. The main questions related to why Brian had not made a full recovery and what could be done to help his pain and discomfort.

Doctors wanted to help Brian mostly through the conventional mainstream approach. They   often prescribed more medications which frequently caused further damage. I sought alternative complementary therapies otherwise known as a holistic approach.

On my journey of discovery I had confirmation that each of us is a unique individual whose needs include psychological, social and physical and all these aspects should be taken into account.

I was concerned to find thousands of others world wide had been damaged by statins. Information from the Centre of Adverse Reactions in Dunedin in 2010 confirmed 11 people in New Zealand had died from simvastatin and they have over 30 reports of rhabdomyolysis in their database. I did not ask about other statins. It is my belief that the  Accident Compensation Corporation and in general, the medical profession and pharmaceutical companies would prefer these statistics were not made public.

So, did we feel that Brian was at fault. No, absolutely not. He did everything the medical profession advised him to do. Were the doctors to blame? Certainly most doctors we speak to believe what the national guidelines tell them – cholesterol is a potential killer and the lower the better. I believe most doctors are unaware of the vast amount of evidence supporting healthy cholesterol. I believe responsibility lies with the producers of medications namely the pharmaceutical corporations. It should be their job to give explicit information about their products. Results of tests and studies need to be clearly described in real life situations.

The Cochrane Collaboration is an international non-profit and independent organisation, dedicated to making up-to-date, accurate information about the effects of healthcare readily available world-wide.

Perusing the Cochrane Library is revealing. “Caution” is urged among GPs who prescribe statins. For primary prevention of cardiovascular disease, if 1000 people were treated with a statin for five years, 18 would avoid a major CVD event. Published Online: 31 JAN 2013

             Should we all aim to lower cholesterol?

In 1955 Ancel Keys who was a scientist in the United States of America did a study about diet and heart disease. In the results he cherry picked seven countries out of the 22 studied to prove what he wanted to prove. The countries he chose had a diet relatively high in saturated fat but also in sugar, he left out countries like France and many others who consumed a huge amount of saturated fat but had very little heart disease. If all the information had been disclosed it would have made a great deal of difference to the graph. It became known as the Seven Countries Study.

 

It is commonly believed that saturated fats and dietary cholesterol are “artery clogging bad fats” and cause heart disease. These ideas have been shown to be false by scientists such as Linus Pauling, Russell Smith, George Mann, John Yudkin, Abram Hoffer, Mary Enig, Uffe Ravnskov and many other prominent researchers.

 

I believe we have all been given incorrect information about cholesterol for decades. This misinformation has been fed to us from pharmaceutical companies. We haven’t been told about the importance of cholesterol and how taking drugs that prevent our bodies from synthesising cholesterol risks damaging the muscles, heart, brain and almost every part of our system.  [Ed note:  One of the reasons that the statin drugs used to lower cholesterol can have such severe side effects is that they also prevent the synthesis of CoEnzyme Q10 which is crucial for cellular energy production. Supplementation with CoEnzyme Q10 has the potential to reduce the risk of severe side effects from statin drug use, but many people are not aware of this.]

Throughout this ordeal we have been supported by family and friends in New Zealand and overseas. We have had correspondence from doctors and researchers worldwide who have themselves stepped out on a limb to challenge the drive to lower cholesterol and continue to tell us to challenge the Accident Compensation Corporation.

I wonder about the cosy relationships between Pharmac and Big Pharma or the Food and Drug Administration (FDA) and major corporations around the world. Who is working for whom? Decisions are being made based on profit and not always what is the best for our health.

 

This is my personal perspective and I make no apology for my zealous viewpoints and passion. I wish you well.

 

And, I can’t help but close with one of my favourite quotes from Star Trek.

 

Spock says:

“….. Logic clearly dictates that the needs of the many outweigh the needs of the few.”

 

I believe we all are the many and the few are those who seek to make a profit at the expense of humanity.

 

Editor’s note: In a non-emergency situation it is always prudent to look up the side effects of any medication that you may be prescribed before you take the drug. The website of Medsafe, NZ’s drug and medical device regulator has a search engine in which you can look up any drug that you have been prescribed:  http://www.medsafe.govt.nz/profs/datasheet/dsform.asp

 

You may need to use a medical dictionary to look up some terms.  There are free-toaccess oneline medical dictionaries.

 

Further information on statins:

 

For more information feel free to read the following:

http://balanceyourlife.ca/archives/671    links to a wide variety of info

http://wp.rxisk.org/the-legacy-effects-of-statins-a-role-for-rxisk/

Changing Habits, Changing Lives by Cyndi O’Meara

Lipitor Thief of Memory by Duane Graveline

The Fat Revolution– Christine Cronau

The Cholesterol Conspiracy 2nd Edition by Dr Ladd R Mc Namara MD

The Great Cholesterol Con by Anthony Colpo

Overdose by Jay S Cohen

The Great Cholesterol Lie by Dr Dwight Lundell MD

The Great Cholesterol Myth by Dr Malcolm Kendrick

Nourishing Traditions by Sally Fallon and Mary Enig

The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs Dr. Barbara H. Roberts

The Creative Destruction of Medicine Cardiologist Eric Topol

Heartbreak and Heart Disease: Cardiologist Stephen T. Sinatra

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004816.pub5/abstract

 

Subscribe To Our Newsletter

Subscribe To Our Newsletter

Join our mailing list to receive the latest news and updates from the team at The New Zealand Journal of Natural Medicine.

You have Successfully Subscribed!