In the same week that the MHRA has advised that parents and carers should not give oral echinacea to the under 12s, a government study has found that at least a third of all drugs given to the same age group have never been through clinical trials for children, nor are they approved or licensed for anything other than adult use.
It seems like only a couple of weeks ago GSK was being fined in America for kids using its unapproved drugs. So are the UK Government going to take action?
Not quite yet. The Department of Health report, ‘written by leading child health experts’ is calling for an investigation by the drugs’ watchdog (the Medicines and Healthcare products Regulatory Agency). Could this be the same MHRA?
Believe it or not, prior to 2007, drugs companies had no obligation to test medicines on children!
New drugs must now be tested on kids before being licensed but drugs already out there? Don’t be silly.
So the EU and MHRA effectively ban echinacea ‘due to the possible risk of rare allergic reactions in under 12s’, but 30 per cent of all drugs given to under 18s, and 95 per cent of all drugs given to babies in intensive care haver NEVER been tested on children.
Is there any chance of a ‘rare allergic reaction’ from any or all of these adult drugs used on a three day old baby? The list would include painkillers, antibiotics, asthma inhalers and even, yes you’ve guessed it, those perfectly safe cancer drugs, that have never been known to cause a side-effect even in an adult.
In a statement which sounded dangerously like it had been borrowed from a herbalist or a vitamin salesman, Warren Lenny, a professor of respiratory child health was quoted in the press as saying ‘By no means are we using dangerous medicines. If a medicine has been on the market for 30 years, no company is going to spend millions of pounds testing it on children.’ However, he went on to say that it has been shown that using an unlicensed drug on children does indeed increase the risk of side-effects.
Another Professor, Ian Lewis of Alder Hey Children’s NHS Trust, sounded even more like a herbalist when he said, ‘Most of the drugs we use in Children’s cancer like leukaemia have not been formally tested in children but have cured many of them’.
Apparently, we are going to get a formal response from the Dept of Health later this year.
The world is becoming a very weird place.