As many of you know, statins are the acclaimed LDL-Cholesterol-lowering drugs which are amongst the biggest-selling medicines in the world, generating billions ($27 billion in 2009) in revenue for pharmaceutical companies (ref. 1).

But what you may not be so familiar with is the heated controversy surrounding their efficacy. This past month has seen that controversy come to a head in the UK.

This debate was caused by the outraged response of doctors and experts to the declaration on statins by the National Institute for Healthcare and Excellence (NICE)

NICE declared (ref. 2) that they would be relaxing the guidelines for statin use, so that more over-50s routinely take a statin as a ‘just-in-case’ remedy against heart disease. Consequently, statin prescriptions in the UK are expected to rise from the current seven million to 12 million.

Why did NICE take this action and why has it caused so much heated debate? This blog attempts to reflect on these questions and decipher the facts from the fiction.

The Rationale For Statins

According to Professor Mark Baker, Director of the Centre for Clinical Practice at NICE: "Cardiovascular disease maims and kills people through coronary heart disease, peripheral arterial disease and stroke. Together, these kill 1 in 3 of us. Our proposals (particularly for the over-50’s) are intended to prevent many lives being destroyed.”

Do you think this assumption is correct? Let’s see…

First, the assumption is based on the premise that statins reduce cholesterol levels – especially the ‘bad’ LDL - cholesterol in the blood, therefore lowering the risk of a heart attack or stroke.

Yes, there is evidence to support the contention that statins help to prevent the formation of cholesterol and reduce LDL cholesterol. This is especially the case in a tiny group of people with familial hypercholesterolemia, an uncommon genetic defect that causes very high cholesterol levels (ref 3)

However, it has NOT BEEN CLINUCLLY PROVEN that statins significantly lower the risk of dying overall from all causes. Statins have not been shown to treat the underlying causes of heart disease.

The Rationale Against Statins

Indeed, lack of clinical evidence is a just one of the key points summarised by the doctors’ and experts’ written response (ref. 4) to the NICE proposal. In essence this specifies that:

1. The ‘medicalisation’ of five million healthy individuals is inappropriate and clinically unsubstantiated “Where is the evidence to prove that treatment of elevated cholesterol levels with statins in otherwise healthy persons decrease mortality or prevent other serious outcomes?”
2. The assumption that statins have no negative side effects is clinically flawed: “Using statins might change what it says on your death certificate, but not the date is gets written…Statins have a lot more side-effects than opinion leaders state. To say they have no side-effects is complete and utter nonsense.”
3. The extreme conflict of interests amongst those involved in the clinical studies referred to by NICE is wrong: “The data driving NICE guidance on statins comes almost entirely from pharmaceutical company funded studies. 8 members of NICE’s panel of 12 experts have direct financial ties to the pharmaceutical companies that manufacture statins. Furthermore, some members of the guideline panel are also involved in next generation, more expensive, cholesterol lowering drugs, which are not yet on the market.  Furthermore, these data are not available for review by independent researchers.”
4. The overdependence on industry data raises concerns about possible biases: “Extensive evidence shows that industry funded trials systematically produce more favourable outcomes than non-industry sponsored ones.”
5. The NICE recommendations have led to a loss of professional confidence:GPs feel that this guidance is a ‘step too far’. It is instructive to note that almost six out of ten GPs (57%) oppose the plan to lower the current 10 year risk threshold for primary prevention, while only 25% support it. Furthermore, 55% would not personally take a statin or recommend a family member does so based on a 10% 10 year risk score.”

The Evidence Against Increases

In addition to the above studies referenced by the experts which question the benefits of statins, we also have independent studies showing how:

• the progression of coronary artery calcification, which is the hallmark of potentially lethal heart disease, is increased with statin drug use. (ref. 5)
• statins increased the risk of type 2 diabetics in postmenopausal women by 48 % (ref. 6)
• statins appear to come with many other potential side effects. In fact, as of 2009 there were well over 900 studies proving their adverse effects (ref. 7). One of the primary mechanisms of harm appears to be CoQ10 depletion. If you take statin drugs without supplementing with CoQ10 (or ideally, the reduced form, called ubiquinol, which is far more effective), your health may be seriously compromised.

Plus we also have evidence showing why the Jupiter study (ref. 8) was so flawed. The Jupiter study is one of the largest ever trials for statins. It concluded that: “men and women with elevated hsCRP (high-sensitivity C-reactive protein) and low LDLC are at substantial vascular risk... statin therapy can cut that risk by half.”.

Revision : “Plus we have evidence showing why the Jupiter study (ref. 8) was so flawed. The Jupiter study is one of the largest ever trials for statins. It concluded that statin therapy can reduce unbalanced cholesterol levels. 

But Independent studies clearly illustrate how flawed Jupiter was (ref. 9). These independent studies concluded that “The trial was flawed. It was discontinued after fewer than 2 years of follow-up, with no differences between the two groups on the most objective criteria.  The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors. In addition, the meta-analysis of 11 randomized controlled trials, found no evidence to back up the JUPITER trial claim that statins can reduce your risk of death when used as primary prevention against heart disease.”

Given all the above evidence questioning the health benefits of statins, perhaps NICE simply misunderstands the nature of cholesterol, heart disease and statins?

Has NICE Mis-Understood Cholesterol, Heart Disease and Statins?

One cannot help but wonder if the attitude of NICE reflects a very common mis-understanding about basic human biology and the function of cholesterol.

It is too simplistic to simply say that there is "good" or "bad" cholesterol. Both HDL and LDL cholesterol perform vital functions in your body.

HDL (high density lipoprotein) and LDL (low density lipoprotein) are proteins which transport the cholesterol to and from your tissues. Cholesterol in turn is a precursor to your steroid hormones, bile acids, cell membrane walls and vitamin D. Even more importantly, your cells cannot regenerate their membranes without it.

This is why it may be dangerous to bring your LDL levels down too low, as we pointed out in another blog (ref. 10).

Really the main way cholesterol can be viewed as very ‘bad’ is when it is oxidized or damaged. This happens when you eat something cooked in vegetable oils like canola, corn, or soy oil. As soon as the oil is heated and mixes with oxygen, it goes rancid.

Perhaps by now, in the light of all the above concerns with statins, you may be wondering what can you do if you are concerned about unbalanced cholesterol levels?

How Can You Control and Balance Cholesterol?

First we suggest you view cholesterol as performing vital positive functions in your body, which work in concert with other necessary functions. Indeed, when considering your cholesterol levels, it is a vital see those levels holistically in relation to many other indicators like homocystine, triglycerides, blood pressure, apolipoprotein and CRP, as well as the more usual blood and urine results. If you have low or high cholesterol, but healthy results in most of these areas, this must be taken into account.

Then, do your best to lead a balanced lifestyle which includes:

1. Normalizing your insulin levels by eliminating sugar (particularly fructose) and grains.
2. Eating a good portion of your food raw (ideally organic to avoid agricultural chemicals) especially raw fats like virgin olive oil, coconut oil, avocados, raw organic nuts and seeds, organic eggs, organic, grass-fed meats
3. Regular exercise to increase your circulation and the blood flow throughout your body.
4. Avoid smoking and drinking alcohol excessively.

As mentioned above, statins deplete the vital nutrient CoQ10. If you take statin drugs without supplementing with CoQ10 (ideally, the active form, called ubiquinol),  your health, especially cardio-vascular well-being -  may be seriously compromised.

To help prevent this, if you do take statins, please consider supplementing with our Omega 3 QH/Ultra for optimum cardiovascular support. This includes 50mg/day Kaneka QH^® Ubiquinol.

As always, it is important to seek medical advice in regard to your own situation.

However, we hope that this blog has helped to dispel some of the confusion and fiction about Statins.

If however, you still have unanswered questions or concerns about statins, please do express them. Please also share your personal experiences of using statins.

We look forward to hearing your thoughts!

References

1. Value of Statin Global Market  https://www.visiongain.com/Report/581/Statins-World-Market-Outlook-2011-2021
2. The NICE Declaration  and Response to Criticisms http://www.nice.org.uk/newsroom/pressreleases/NICERespondsToCriticismsOfItsDraftGuidanceOnStatins.jsp
3. A long term cohort study showing the efficacy of statins in familial hypercholesterolaemia: http://www.bmj.com/content/337/bmj.a2423
4. The doctors’ and experts’ written response to the NICE proposal:    http://www.nice.org.uk/media/877/AC/NICE_statin_letter.pdf
5. Study showing how the progression of coronary artery calcification, is increased with statin drug use http://www.ncbi.nlm.nih.gov/pubmed/22981406
6. Study showing how statins increased the risk of type 2 diabetics in postmenopausal women by 48 % http://www.greenmedinfo.com/blog/statins-raise-diabetes-risk-48-postmenopausal-women
7. The American Journal of Cardiovascular Drugs cites nearly 900 studies on the adverse effects of statins.http://www.ncbi.nlm.nih.gov/pubmed?orig_db=PubMed&cmd=Search&term=%22American+journal+of+cardiovascular+drugs+%3A+drugs,+devices,
   +and+other+interventions%22[Jour]+AND+Golomb[author]
8. The Jupiter study http://circoutcomes.ahajournals.org/content/2/3/279.full
9. Why the Jupiter study was so flawed http://www.courses.ahc.umn.edu/pharmacy/5822/deLorgeril_Cholesterol%20lowering,%20cardiovasc%20diseases,%
   20and%20the%20rosuvastatin-JUPITER%20controversy_Arch%20Int%20Med%202010.pdf
10. Why Low Cholesterol May be Bad for You http://www.xtend-life.com/news-blog/article/blog/2010/05/17/low-cholesterol-is-bad-for-you