People that know me pretty much know that the words 'not recommended' mean absolutely nothing to me.
When used on drug information leaflets, 'not recommended' serves as a reminder to prescribing physicians that the drug they are about to prescribe to the patient is not recommended for them, be it because they don't have an illness that the drug is indicated to treat or that it could be potentially dangerous.
Last week British tabloid, The Mirror, ran with an article about pensioner Ron Sheppard.
Sheppard had been campaigning for almost 22 years to force changes to the way a steroid [Depo-Medrone] was used on millions of patients. And now, writes The Mirror, "drug company Pfizer has applied to UK drug regulators to change the drug labelling.
"It is likely to be switched from “not recommended” for use in epidurals to “must not be used”."
22 years on and now Pfizer decide that the drug must not be used in epidurals. It would appear that Pfizer know the difference between “not recommended” and “must not be used”, either that or they fear future lawsuits.
“Not recommended” is simply not good enough, particularly when it comes to children being prescribed antidepressants.
Would it be practical for the likes of antidepressant manufacturers to change the patient information leaflets for antidepressants from 'Not recommended for children' to 'Must not be used in children'?
The defence of the pharmaceutical industry has, for many years, been this 'not recommended' nonsense.
"It specifically states that our product is not recommended for use in children", is a line thrown around when pharmaceutical products have been implicated in child/teen suicides. Hidden in their defence, however, are facts that they have promoted the use of antidepressants in children - reps, armed with cash incentives or other lavish gifts have, for decades, persuaded doctors that "not recommended" are just two words that have to appear on leaflets for legal reasons. A rep from Glaxo would have told doctors that Paxil was safe to use in kids...it was the other SSRi's that were unsafe. A rep from Lundbeck would have told doctors that Celexa was safe to use and that it was other SSRis that were dangerous.
That's how marketing works and it was those two words that allowed pharmaceutical companies to get away with it for decades.
If a rep had visited a doctor and offered him cash incentives to prescribe a drug that said “must not be used”, would the outcome have been the same?
"Not recommended" can be written off as a legal requirement, it can be a discussion starter with a pharma rep and doctor, it can be twisted to convince the doctor that it's okay to prescribe adult drugs to children or drugs with a link to birth defects to pregnant mothers.
It's time to change all of that.
The following “must not be used” in children, adolescents and pregnant mothers.
They “must not be used” to treat illnesses other than those indicated on the leaflet.
It doesn't take a rocket scientist to figure out why this has never been done.
'Not recommended' has helped the pharmaceutical industry get away with murder and, at the same time, earned them billions of dollars. Money over life.
Just a small example here.