One of the reasons for gathering evidence in trials is to use it to better treat patients. But what happens if doctors know what should be done in theory but then don’t or can’t do it? This is a far from a theoretical issue for kids diagnosed as ADHD on Ritalin or someone getting one of the heavy tranquillisers known as antipsychotics. They are supposed to be regularly checked for the risks these drugs carry but two recent reports show this rarely happens. It’s a failure that doesn’t incur any penalties, for the medics that is.
It’s nearly ten years since the American FDA recommended that all patients on antipsychotic drugs such as Zyprexa, Risperdal, or Seroquel should be regularly checked for metabolic problems because these drugs, among other side-effects, can cause rapid weight gain and a dangerous rise in blood sugar, which are linked with diabetes and heart disease.
In fact it was failing properly to warn patients about these risks that was a reason for the record $1.4 billion fine levied on the makers Eli Lilly in 2009. A year earlier research had found that only 20 per cent of patients on these drugs had their glucose levels checked and only 10 per cent had the levels of fats in their blood (lipids) monitored, which is a measure of heart attack risk.
Now another study at the University California, San Francisco has found that there is still little monitoring of patients due to a turf war between physicians and psychiatrists over whose responsibility it was. But even after a decade of warnings of what needed to be done there was no sense of urgency. “Care between the psychiatrists and medical care providers must be orchestrated,” ran the conclusion “which is not always easy to achieve.”
The same sort of sense of “yes we should be doing this but it is tricky” emerged from a very good feature on Ritalin-prescribing in the UK that appeared in the Daily Mail last week. Use of this drug has quadrupled in the last decade even though experts have long warned that this makes the “rare”serious side effects such as suicidal thoughts and psychosis more common. And then then there are the less severe ones such as stress, anxiety, heart problems, dizziness and stomach upsets.
Several trends that go along with this rise are alarming. There has been a big increase in prescribing to children younger than 6, even though NICE advises against it and because the longer you take it the less effective it becomes – a sequence that in street drugs is called becoming addicted – many children are getting increasing doses. Some children have been taking it for as long as six years even though one important study found that benefits disappeared after three.
The EU medicines regulator has said that children should be taken off it every year to check that it is still needed but experts say that is widely ignored because health care professionals are too busy. Another safety precaution that is rarely done is weighing the children because Ritalin is closely related to amphetamine, an appetite suppressant widely used as for slimming.
And it may be no better than a placebo. A couple of studies have found that symptoms were just as effectively reduced in children given therapy plus the drug and those given therapy plus an inert sugar pill. And as if all this wasn’t bad enough there is no clear data on what the drug does to a growing brain, although experts think memory loss and depression are likely.
Evidence based medicine doesn’t just mean running big trials – it also means applying the results in a way that benefits patients. Clearly the way these children are being medicated isn’t following any sort of evidence based regime. And there doesn’t seem to be any kind of oversight that’s found in other industries to regulate the situation.