.EDITORIAL: STATINS: PROS & CONS

Statins: Pros and Cons

                                              (first posted October 2015; updated Sept 2017)


If there is one thing guaranteed to strike unease into the hearts of the middle aged and older, it is the words 'high cholesterol' and 'statins' in the GP's office.

Everyone knows high cholesterol can cause fat deposits in blood vessels.  The deposits narrow blood flow and can break off, leading to heart attacks and strokes.  This can be catastrophic for the victim and impacts hugely on the NHS.

For 30 years, doctors have treated high cholesterol with Statins. Statins reduce cholesterol in the overall population but for many individuals, it comes at a cost: side-effects. 

The most common, according to the Mayo Clinic in the USA (See footnote 1 below), are muscle and joint aches, headache and nausea.  Less common but more serious are:

• muscle problems which can damage kidneys
• liver damage 
• cognitive problems such as memory loss and confusion 

It appears the original research into statins looked at their effect on the heart and considered cancer risks but didn't look at other side effects (fn2).  

Now, the medical profession is beginning to acknowledge the severity of statin side effects.  And there are increasing question marks over just how effective statins really are in preventing heart attacks in some people.

Is it any wonder that patients are reluctant to try them, are suspicious and often refuse to take them?

Cholesterol has been the main health issue for the Blogger (See About Me on the Nav Bar).  And though, at 68, the Blogger is in good shape, the cholesterol issue recently came to a head. 

The Blogger is now, warily but with an open and hopeful mind, on a course of low-dose statins apparently with fewer-side-effects.       

Season of 'mists and mellow fruitfulness'  Regents Park London

67goingon50 is about Achieving Great Health and Graceful Aging whatever your years or income..  It is based on the Blogger's experience -- healthy, fit, youthful and drug-free when the blog started at year ago.      

The fact that the blogger is now on statins should not affect readers' trust in the blog.  Despite a desire for privacy, the Blogger is happy for readers to have the opportunity to understand the factors behind the decision.  This editorial is the result. 

The Blogger spent two days researching recent (2015) reports on Cholesterol and Statins in America and the UK. (A drop in the bucket, to be sure.)  This essay is footnoted but is not an academic essay.  If you are interested, read on.  If you can't be bothered to read all of it, at least read the final four paragraphs.


STATINS & CHOLESTEROL

Background 

• Statins are the world's best selling drugs of all time, with no close competitor (fn3) 
• Statins have always attracted controversy.  When they were first prescribed, criticism centred on whether cholesterol has anything to do with heart attacks at all.  Three quarters of people who turn up at American hospitals with their first ever heart attack don't have high cholesterol (fn4) 
• Today controversy focuses on changes in guidelines for recommending statins.  Before 2013, a patient needed to have a 20% chance of having a heart attack within 10 years before being prescribed statins; now it is 10%.  (The percentage is based on age, weight, exercise, smoking and family heath history.)

Do statins work?
According to the Pharmaceutical Journal (fn5), the high-quality Cochrane Report analysed all research studies into statins and concluded that statins reduce 'cardiovascular' events by one quarter'. (Others say a third).  Another way of judging success is cost-effectiveness; Cochrane concluded that statins were likely to be worth the money spent on them.  

So, what's the problem?
The original published research into statins contained no information about side effects (fn6).  This obviously affects the Benefits Risk ratio, or 'Is it worth suffering side effects if health is improved and the risk of death is reduced?'

Furthermore new research indicates statins can lead to increased risk of Diabetes; another report showed statins increased the rate of ageing (fn7).

Leading UK doctors are openly asking just how effective statins can be (fn8) -- especially if prescribed, as per current guidelines, to otherwise healthy people who are not old.
    
But even respected medical journals seem to be in two minds about statins (fn9). 

The Pro-Statin Group say... 

• All drugs have side effects and some people will suffer from them.  It's worth it if your health improves and the chances of illness and/or death are reduced.    
• The evidence for statins is not pulled out of the air; it's high quality and 'we're on the right track' (fn10)  
• The take-up of statins is lower than the medical profession would like because (i) doctors often encourage patients to do everything else (change diet, start exercising, stop drinking etc) before recommending statins and (ii) it takes awhile for patients to enter what's known as the 'adoption cycle' (to accept the drugs.) (fn11)
• It's the Media's fault -- they're scaremongering

The Anti-Statin Group say...

• Increasing numbers of respected Medics are stating openly that for many patients the harm caused by statins may outweigh the benefits (fn12) (67's emphasis)
• The mediterranean diet is 3-4 times more effective than statins for heart health; lifestyle is still considered the key (fn13) 
• Risk scores are based on average outcomes and are not perfect indicators
• For patients who have not had [a heart attack] evidence is far from compelling: 140 people with a five-year risk of less than 10 per cent need to be treated with statins for five years to prevent ONE heart attack or stroke, according to Spectator Health.  
• It's Big Pharma's fault -- they're looking at profits not patients. (According to Anti-Statin Groups)

Big Pharma

• Anyone with a basic knowledge of Research Methods quickly understands that research data is based on populations not individuals.  Moreover, published research often focuses on certain slices of data and is skewed toward people who are the most sick and usually male. 
• Some people involved in the decision-making process relating to guidance for prescribing drugs have links to drug companies which may or may not be disclosed.
• Drug companies have a 20 year period when no one else is allowed to produce or sell the drug.  That's fine; after all billions can be spent on research before a drug reaches the market.  After 20 years, prices tend to fall.  The NHS is more likely to prescribe such 'generic' drugs.  Conspiracy theorists believe the decision to prescribe statins to those with a 10% chance of a heart attack within 10 years, instead of the previous 20%, is linked to the drug companies losing exclusive selling rights.    

The Media 

• Despite the Leveson Report (on Phone Hacking), the media aims to report and not create news.  Is the media sensationalist?  Some parts of the media, sometimes.  Talk of adverse/harmful side effects from statins has been around for years and research is beginning to question whether the benefits of statins really do outweigh the risk. The Media would be remiss in not investigating and reporting this.
• Huge corporations often insist there is no clear link between its products and damaging side effects...until the company finds itself in court after a whistle-blower blows the whistle. How many modern money-making drugs have a murky marketing history?
• Media reports on drugs come from respected medical journals, broadsheet newspapers such as the Telegraph and Guardian (not just tabloids like the Express) and major tv networks.   
• Drug companies and medical professionals do not help their 'the-media-is-biased' approach when they shut down reports questioning the efficacy of Statins.  The Australian Broadcasting Company's two-part series on the side effects of statins was banned after complaints from the pharmaceutical industry.  (fn14).

What's happening in the NHS?

The UK is not immune to pressure though it may be more resilient.

In 2014, the respected British Medical Journal (BMJ) published two articles on the adverse side effects of statins in the wake of the new prescription guidelines.  

Oxford professor Dr. Rory Collins, whose research was used to support putting millions on statins, demanded a retraction.  An independent panel set up by the BMJ to look at the data rejected his demands.

Dr Collins is an interesting man.  He has been Head of the Cholesterol Treatment Trialist' Collaboration (CTT) for 20 years. CTT gathers and looks into data relating to statins.  

Dr Malcolm Kendrick' book, The Great Cholesterol Con, clearly shows which side of the divide he is on.  But his scathing criticism(fn15) of Dr Collins is worth reading: '... for a number of years, people have been trying to get Rory Collins to release the data he and (the CTT), holds on statins...He has stubbornly refused to let anyone see anything. He claims he signed non-disclosure contracts with pharmaceutical companies who send him data, so he cannot allow anyone else access. Please remember that some of the trials he holds data on were done over thirty years ago, and the drugs are long off patent."

67 might not be in a position to assess the Sunday Express' conclusion (fn16) that Dr. Collins' actions "points to a massive cover-up and scandal related to statins".   

But in February 2015, Dr Collins announced he was reassessing the data on statins to determine if possible drug side effects might have been missed previously.  He sent an e-mail to the Sunday Express (fn17) stating that ‘his team had assessed the effects of statins on heart disease and cancer but not other side effects such as muscle pain.’  He was accused of "backtracking". 

In July 2015, the Chief Medical Officer for England called for an independent review of the safety and efficacy of medicines.  She said recent controversies over the use of medicines have damaged faith in the way research is carried out and presented (fn18).  The report is due by the end of the year.

Given the above, why take statins at all?

According to the Mayo Clinic, there are several factors increasing the risk of heart disease:

• smoking
• high cholesterol (above 4.9)
• high blood pressure
• overweight
• family history of high cholesterol or heart disease
• not exercising
• poor stress or anger management
• older age

Change any lifestyle choice and the risk of heart disease is likely to fall.

On the other hand, factors beyond a person's control such as family history and age can push an otherwise healthy person towards the high risk category.  Not managing stress can also push you over the line. 

The fact that the subject has a healthy lifestyle (good diet, physically active, no drinking or smoking) is, in such cases, becomes more or less irrelevant.

Doctors and Statins

67goingon50 admires GPs.  People become doctors because they want to help others and they mostly act in good faith. Sure, there are a few who push medication on a patient without considering the patient's constitution and values.  

But GPs are increasingly willing to take a different approach to statins.  They are prepared to take into account whether the patient is actually willing to  take a  pill daily (and perhaps for the rest of their lives) and their attitudes toward side-effects (fn19).

GPs work hard and have lives, too.  How many could  find time to spend a couple of days looking into research on statins?  GPs also work under the direction of NHS guidelines.

We need to have a look at what we want the NHS to do and how we want to achieve it.  Part of the process will involve personal research; part through communicating to policy makers.  Let politicians, medical practices, NHS executives know if you are uneasy about NHS methods; find out how they think the NHS can change for the better without injecting vast sums of money but without losing its central ethos. 


The Blogger's Decision

Having high cholesterol despite modifications to diet, combined with family history and age, is a flashing neon warning sign where doctors are concerned.  

It seems no amount of dieting or change of diet is likely to make a difference to this category and that includes the Blogger.  Some intervention was required. 

That is why the Blogger embarked on a course of statins, low-dose and apparently with fewer side-effects than other statins. 

If lifestyle choices are not helping and may not be able to help, who wouldn't want be prepared to take other measures to prevent heart attack and stroke?  Especially at (dare one say it) the Blogger's age, even if the Blogger is otherwise healthy and fit?   
  
In one sense, the matter was taken out of the Blogger's control.  
For the moment.
  
And that could be the subject of another Cholesterol & Stains editorial in due course! 

Note: 3 weeks after starting a course of medical statins, the Blogger came off them.  'Natural' statins from a health food shop were substituted but they also produced side effects similar to medical statins.  

Feb 2016: 
Several 'last-ditch' changes were made to diet and lifestyle. Particular focus was placed on stress-busting measures; stress is not directly linked to cholesterol but the only new factor in my life was exceptional stress.  

My last test showed cholesterol down from well above 7 to below 7.  It's not a big fall but it's going in the right direction --and it's been achieved without statins.   

B Lee/Bright Sun Enterprises accept no liability for the consequences of any actions taken on the basis of the information provided.

(See Statins and Me, a Follow-Up)
(See also Dr Mark Porter, The Times)

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Footnotes: 
1.  http://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statins/art-20045772
2. http://healthimpactnews.com/2015/statin-drug-scandal-cholesterol-lowering-drug-researchers-start-back-tracking
3. http://healthimpactnews.com/2015/statin-drug-scandal-cholesterol-lowering-drug-researchers-start-back-tracking/
4. http://onpoint.wbur.org/2015/07/16/statin-use-cholesterol-reduction-heart-health
5. http://www.pharmaceutical-journal.com/opinion/comment/give-statins-to-those-most-in-need/20065643.article

6. http://healthimpactnews.com/2015/statin-drug-scandal-cholesterol-lowering-drug-researchers-start-back-tracking

7.http://www.telegraph.co.uk/news/health/news/10900296/Evidence-for-NHS-statins-advice-wholly-inadequate-says-expert.html
8. http://www.pharmaceutical-journal.com/opinion/comment/give-statins-to-those-most-in-need/20065643.article
9. http://www.pharmaceutical-journal.com/opinion/comment/give-statins-to-those-most-in-need/20065643.article
10.. http://onpoint.wbur.org/2015/07/16/statin-use-cholesterol-reduction-heart-health: Dr Donald Lloyd Jones
11, http://onpoint.wbur.org/2015/07/16/statin-use-cholesterol-reduction-heart-health.
 12. http://www.express.co.uk/life-style/health/608210/statins-age-you-faster-new-research-suggests-long-term-use-warning: Prof Kim McPherson
13. http://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statins/art-20045772
14.  http://healthimpactnews.com/2015/statin-drug-scandal-cholesterol-lowering-drug-researchers-start-back-tracking/
15. http://healthimpactnews.com/2015/statin-drug-scandal-cholesterol-lowering-drug-researchers-start-back-tracking/
16.  http://healthimpactnews.com/2015/statin-drug-scandal-cholesterol-lowering-drug-researchers-start-back-tracking/

17.  http://healthimpactnews.com/2015/statin-drug-scandal-cholesterol-lowering-drug-researchers-start-back-tracking/

18.  http://www.bbc.co.uk/news/health-33127672

19.  http://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statins/art-20045772