For any drug or device, the EMA almost always takes longer than the FDA to process the licencing application [fact] . . . because the Feds care less about the risks [supposition]. Licensing requires success on two complementary fronts
a) Efficacy the drug must cure or increase QALY for some people some of the time
b) Risk do not kill, disable or make miserable too many people from the side-effects. The FDA will give MegaPharm a pass on Risk: the EMA is more primly risk-averse, so takes more time.
Why side-effects? Because oral meds are a really blunt instrument. Biomedical research has the most superficial understanding of what goes on inside. We only have 23,000 protein-coding genes to make the enzymes and receptors which control all the peculiar and particular metabolic processes essential for life as we know it, in trillions of subtly different cells. Some of these molecular entities must be double-jobbing. And they are:
- adrenalin is both a neurotransmitter and a hormone
- glycine is both a neurotransmitter and an amino acid built into pretty much all proteins
- The enzyme lactate dehydrogenase is used in duck eyeballs for its optical properties
- bone has essential engineering properties but also serves as a calcium reservoir.
- β-defensin 103 is both an anti-microbial peptide and a determinant of coat colour
All this back-story came crashing towards me as I read a long form BBC essay The medications that change who we are on unwanted side-effects. Frightening stats in there: US consumes 50,000 tonnes [= 50 bn grams] of paracetamol each year enough for 300 pills/yr for every man-woman-and-child.
Statins, the cholesterol-lowering drugs are very widely prescribed by Irish doctors, [press release NUIG with BMJ link] indeed they are lashed out in handfuls across the First World for anyone whose cholesterol is above some arbitrary threshold. I was given the option when my last MOT showed my cholesterol was high; I said I'd keep the money and eat less bacon [I lied about the bacon]. Statins are cheap as chips [because the market is now so huge], especially if the government is paying [50% of Irish adults are on a medical card]. So there is a tendency to think that, even if the positive benefit is marginal at least they do no harm. Similar faulty reasoning about antibiotics saw them over prescribed for 50 years so we now have an anti-biotic resistance crisis with MRSA and CRE. For any medication it is handy to do a back-of-envelope number needed to treat NNT calculation. For statins, for low-risk people, for every 200 people prescribed and taking statins 1 won't have a non-fatal heart attack - NNT = 217. Rohin Francis says for high-risk people, including those who've had one Event take the statins! How many people have to take the drug for 1 person to be saved. I've done these for Ringer's /saline drips and prostate interventions.
Mais revenons à nos statins: It seems that for some people, statins can have frightening psycho-active side-effects: road-rage, domestic assault and suicide. Whaaaa!? But if you think a bit, it has the ring of truth. Statins lower cholesterol <butter!>. What is cholesterol <butter!>?
- To a
hammerdoctor everything looks like a naildruggable target. Cholesterol is a small molecule that we are consuming <butter!> far too much, the body plasters the excess on the inside of blood-vessels because the enzymatic cholesterol turn-over mechanism is overwhelmed. Eventually, in some people, the cholesterol totally occludes the coronary artery, <infarction!>, the heart is starved or oxygen and glucose and the patient dies.
- To a human physiologist [that would be me, I've been teaching it for seven years now and I have a body] cholesterol looks like a small molecule with a strong structural similarity to aldosterone, cortisol, estrogen and testosterone. Why wouldn't cholesterol act as a hormone? Why couldn't tricking about with its concentration by statins have physiological and psychological effects?
Does this make you think about Gardasil and HPV? After risk-assessment, I'm still on the side of mass vaccination of girls [and boys] before they start sharing bodily fluids but we really can't sweep those who have adverse effects under the denial carpet.