Just in case drugs – the incongruence of RCT gold standard

See full size imageGiving drugs packed with unpleasant and dangerous side-effects to healthy people to prevent disease – just in case – apart from being completely illogical, has proven to be dangerous and not to work.

NICE is now recommending that aspirin should not be given as a preventive intervention for cardiovascular disease after years of guidelines advocating that healthy people should take it regularly – just in case! And it’s not as if the many serious side-effects of aspirin (which include stroke and stomach bleeding to mention just a few) weren’t known. The BMJ talked about it as far back as 2002 when they published ‘Effectiveness and safety of aspirin may be overrated’ (http://bmj.com/cgi/content/full/324/7329/0/a). Reputable evidence based publications and research reviews have also shown for many years that aspirin doesn’t prevent anything.

In 2006 the BMJ published figures showing that a quarter of a million people are admitted to UK hospitals every year after suffering a serious reaction to a prescription drug – aspirin being one of the drugs that are most likely to cause a serious reaction. (British Medical Journal, 2006; 332)

So one would think that a lesson had been learned but apparently not!

You might have heard about the latest ‘just in case’ wonder drug known as the Polypill (or Polycap or ‘the Red Heart pill’). It has been hailed as the drug which will save thousands of people from dying of cardiovascular disease. All we have to do is take one pill a day while we are healthy (recommended age is 55 or over) and voilá – no worries about heart problems.

If only! Guess what one of the ingredients in the Polypill is? Our good old ASPIRIN (100 mg of it)! Plus (according to a BBC report and WebMD):

1. A statin drug (Simvastatin) to lower cholesterol. Possible side effects: kidney and liver damage, muscle pain, joint pain, weakness,; constipation; diarrhoea; flushing (eg, dizziness, itching, redness, tingling, warmth); headache; nausea; runny or stuffy nose; stomach upset plus possible severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; muscle pain, tenderness, or weakness (with or without fever and fatigue); pale stools; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; yellowing of skin or eyes.

Three blood pressure-lowering drugs:

2. ACE inhibitor (Ramipril) Possible side effect: persistent cough, dizziness, skin rash, swelling of face and throat

3. Diuretic (Hydrochlorothiazide) Possible side effects: Weakness, dizziness, or a spinning sensation (vertigo), Low blood pressure (hypotension), Diarrhoea, nausea, vomiting, constipation, and stomach cramps, Increased blood sugar (hyperglycaemia), Electrolyte imbalances, including low blood sodium (hyponatremia), low blood potassium (hypokalemia), and low blood chloride (hypochloremia), Sensitivity to the sun, Muscle spasm, Pancreatitis (inflammation of the pancreas), Hair loss (see Hydrochlorothiazide and Hair Loss), Erectile dysfunction, also referred to as ED or impotence

4. Beta-blocker (Atenolol) Possible side effects: Cold fingers and toes; diarrhoea; dizziness; drowsiness; nausea; tiredness or weakness, severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue fingernails, toenails, or palms; decreased sexual ability; fainting; mental or mood problems; persistent dizziness or light-headedness; shortness of breath; sudden, unusual weight gain; swelling of hands, ankles, or feet; unusual bruising or bleeding; unusually slow heartbeat

5. Folic acid (to reduce the level of homocysteine in the blood which is another risk factor for heart disease): completely safe and free from side effects. Easily obtained from spinach, avocado, lettuce, walnuts and many other types of food.

ACE inhibitors can also deplete our bodies’ stores of zinc (“Popular Drugs that Steal Nutrients,” Frederic Vagnini, M.D., of Weill Cornell Medical College). Zinc is an antioxidant and anti-inflammatory (helping prevent heart related diseases) and inhibits abnormal blood clotting that contributes to heart disease

So, the way it works is as follows: if you are healthy, free of any cardiovascular complaints, have a good diet and are over 55, you are advised to take one polypill a day, deplete your body from useful minerals, and risk one or many of the known side effects above.

Then they want to make us accept that the same Randomised Controlled Trials that allow such incoherence should be 100% relied upon to make decisions affecting public health! That may be so – through the looking glass with Alice.

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