Health Authorities in Germany, France and Belgium claim that food supplements containing Red Rice extracts produce the same side effects as the cholesterol-lowering medicine Lovastatin® ! But, do they really ? Should you consult a medical doctor before you start taking Red Rice capsules ? Is there reason to be afraid ? Or, is this just another frivolous attack on food supplements for the benefit of the pharmaceutical industry …
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Red Rice, Lovastatin®, Monacolin K and Cholesterol
On 15 January 2020, the German Federal Institute for Risk Assessment (“BfR”[I]) issued an official Warning that Red Rice capsules should only be taken after having consulted your physician. While it is always a good idea to keep your doctor informed about what you eat and drink, what might be the reason for the Institute’s warning ? Well, the active substance in Red Rice supplements, which is called Monacolin K, is also the active ingredient in medicinal cholesterol-lowering ‘statins’ such as Lovastatin®. Lovastatin® is prescribed in dosages ranging from 20mg to 80mg. The quantities of Monacolin K found in Red Rice food supplements range from 3mg to 10mg.
Maintaining normal blood cholesterol levels
In 2011, the European Food Safety Authority (EFSA) determined that, on the basis of pertinent scientific evidence, the daily intake of 10mg Monacolin K contained in Red Rice shows a beneficial effect on LDL-cholesterol concentrations in individuals with hypercholesterolaemia. EFSA confirmed that the effect of Monacolin K on LDL-cholesterol concentrations is well established and that the mechanism by which Monacolin K can contribute to the claimed effect is well known. EFSA considered that the following wording reflects the scientific evidence: “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol concentrations”. [ii]
Side Effects of Lovastatin®
But, in its Opinion, EFSA also referred to the restrictions of use that concern Lovastatin®. When taken in the prescribed dosages of 20-80mg, Lovastatin® produces serious and unpleasant side-effects. In its Warning, the German Risk Assessment Institute writes: “Possible side effects of lovastatin include headaches, nausea, diarrhoea, weakness, skin rashes and muscle cramps. In rare cases, it can also disrupt kidney and liver function or damage skeletal muscle (known as ‘rhabdomyolysis’). Medicinal products with the active ingredient lovastatin require a prescription. In all cases, the doctor will weigh risks against benefits to decide whether it makes sense for a patient to receive a medication with lovastatin.”
Does Red Rice have side effects ?
Does the daily intake of Red Rice that provides a dosage of, let’s say, 2x5mg Monacolin K produce the same side effects as the daily intake of 20mg or more of Monacolin K provided by Lovastatin® ? The BfR doesn’t hesitate to state that “the monacolin K contained in these [Red Rice] products can also cause the same side effects as listed above.” But, given the fact that there is practically no evidence underpinning this warning, the warning comes down to mere speculation and fear mongering. After all, the minimum recommended dosage of Lovastatin® is twice the dosage recommend in EFSA’s Red Rice Monacolin K’s health claim Opinion. The maximum dosage of Lovastatin® is no less than 8 times the dosage recommended by EFSA in its monacolin Opinion.
Scientific Proof of risk of Red Rice is lacking
There is no scientifically valid reason to associate the potential risks linked with the lowest dosage (20mg) of Lovastatin®with the highest (10mg) daily dosage that can be ingested by using Monacolin in accordance with EFSA’s Opinion. To infer or suggest that the potential side-effects of Lovastatin®’s therapeutic dosage would have to be taken into consideration in the context of assessing the potential risk of 10mg or less Monacolin as a food component would require a solid scientific substantiation unrelated to any of the findings concerning the ingestion of Lovastatin®. That scientific substantiation does not exist.
BfR’s double talk
However, on the basis of the undisputed side-effects of Lovastatin®, the BfR assessed that in terms of the “probability” of a moderate to severe impairment to health from the consumption of food supplements that provide red yeast rice, this “probability” must be assessed as “possible.” In terms of risk assessment, this is double talk. There are no possible probabilities, just as there are no probable possibilities. In genuine risk assessment, as in everyday language, there is an enormous difference between things that are probable and those that are possible. If you’re being asked whether you’ll be buying a new car, “probably” and “possibly” make quite a difference.
Prevent risks that are certain, rather than those that are possible
In any case, when the chance that Red Rice may produce an adverse effect is assessed as “possible,” that places the risk in the lowest category of risks, which range from certain, to probable, to possible, to none. Few people, however, are trained to distinguish certain risk of harm from uncertain risk of harm. Moreover, most of us equate risk of harm with actual harm. After all, we live in a risk-avoiding society, and a warning of risk is in most cases sufficient to raise fear. It is out of fear that we try to avoid risk of harm as if it were actual harm. In fact, creating fear is what this kind of risk assessment is all about. But then, think again, why would you fear a risk that’s possible ? There are thousands of such risks in our every day lives and we don’t seek the advice of doctors, experts, authorities or institutes to assess whether such minimal risks will outweigh the benefits. Isn’t it much safer and sensible to fear risks that are ‘certain’, such as the risk that you may have a car accident when you take the road ?! In this regard, when we apply the BfR’s method of risk assessment to grade the risks involved with taking Lovastatin®, these risks would have to be classified as “certain.” Better avoid them when you can.
The benefits of Red Rice are certain, the risks are not
When it comes to the benefits of red Rice, even the BfR must admit that they do exist. “In Asia,” so advises the Institute, “red yeast rice has long been consumed on account of its ability to lower cholesterol levels, and also to treat digestive problems as well as cardiac and vascular disorders.” These benefits are not “probable” or “possible,” no, they are certain. So, suppose you’d have to weigh certain benefits against a risk that’s assessed as “possible,” it probably won’t take long to reach the decision that you’ll go for the benefits and take the risk that some reversible and transient adverse effects might possibly occur. Not so the BfR. After all, it’s business is risk assessment. But, in the case of Red Rice, the BfR failed to explain how many people that take Red Rice may possibly encounter a moderate or severe adverse effect. One out of thousend, 2 out of thousend, 5 out of 10.000 ? Who can tell ? Not the BfR, since it takes an enormous amount of people to establish whether a possible risk does indeed produce the adverse effect associated with the risk, and if so, in how many people, and, if so, in what level of severity.
Reducing the risk of cardiovascular problems
The interesting thing about the BfR’s Opinion is that to warn you about legitimately marketed Red Rice food supplements, the Institute must acknowledge and confirm the serious side-effects of Lovastatin®. In mainstream medicinal practice these side-effects are mostly played down when statins such as Lovastatin® are being prescribed. It’s alleged benefits receive most of the attention, even though in recent years, the benefits of statins have become highly questionable, perhaps even non-existent. But, let’s for the sake of argument assume that the lowering of cholesterol is a beneficial effect. In that case, shouldn’t the BfR advise, instead of advise against, the use of Red Rice. Why ? Because EFSA claims that taking Red Rice Monacolin K contributes to the maintenance of normal blood level concentrations. And this, in turn, seems to reduce the risk of cardiovascular problems. But, the BfR prefers to ignore that risk. When it comes to what the BfR describes as “Controllability by the consumer,” meaning how the consumer can control the possibility of an adverse effect, it suggests “Controllable with precautionary measures” and “Controllable by avoidance.” In the latter case, by avoiding a possible risk you will also deprive yourself of the alleged certain benefits of Red Rice.
The choice is all yours !