Prescribing drugs with no evidence just got a bit easier

Recently I had a revealing “discussion” with a very senior and respected academic about whether illegal marketing by drug companies was putting patients at risk. By the end he was claiming my view – it clearly is dangerous and even heavy fines were not enough – merely enriches lawyers and pushes up prices paid by the NHS. In return I claimed that by denying there was a problem and claiming there was no evidence of any company wrong-doing in the UK, he was contributing to patient deaths.

Afterwards my initial response was amazement that there was even room for disagreement. It was like hearing American senator or presidential aid deny the American military used torture. Maybe he just longer kept up with the literature.

But then it occurred to me that this was not just one ignorant apple. The fact that a senior figure, one who sits on influential committees and decides policy, felt comfortable expressing those views to a journalist, suggests that despite the river of revelations about drug company wrong-doing there is still an alarming level of complacency at the top.

Just in case you are thinking that this is very one-sided argument – I would claim my views are obviously right and his wrong, wouldn’t I? – let me sketch in a bit of background. Drugs are licensed to treat a particular condition – epilepsy, depression, pain – after trials have shown they are more effective than a placebo in randomised trials. So doctors are practising evidence based medicine when they prescribe them for that condition. (Let’s ignore all the ways this process can be distorted).

Evidence-free prescribing

Prescribing a drug for a condition for which it doesn’t have a licence – an anti-epileptic drug to control pain, for instance – is known as off-label prescribing. Done properly it is perfectly legitimate. Doctors have to have the freedom to decide that if a patient is no longer responding to the licensed drugs they will try something else when there is a good scientific case for believing it might help. However there’s evidence that 70% of American off-label prescribing is based on no evidence at all.

The illegal element comes in when drug companies instruct their sales force to go out and promote drugs to doctors for uses that don’t have a licence. The reason it’s a problem is that it completely undermines the whole notion of evidence based medicine. A trial tells you how patients with one condition respond to certain doses of a drug, not whether it will work for something else. Boosting its use for a different condition makes collecting information about risk and benefits almost impossible.

However the drug company has a big incentive to do it because it boosts sales and saves them the heavy costs of running more trials. Just how beneficial is illustrated by the fact that in America just three companies have been fined an astonishing six billion dollars for illegal marketing in the last few years with little effect on the practice. The fines are regarded as simply the cost of doing more business.

Pushing evidence-free drugs to the elderly

One of the worst cases of illegal marketing involved the antipsychotic drug Zyprexa (olanzapine) – a heavyweight tranquilliser licensed to treat patients with schizophrenia. Court records from America show that the manufacturers hatched a program in the early 2000’s called Viva Zyprexa specifically aimed at encouraging getting doctors to prescribe it off-label to patients with Alzheimer’s It was very successful and hundreds of thousands of patients were put on the Zyprexa and other antipsychotics both in America and the UK.

This was despite the fact that the evidence kept coming in to show that these drugs were positively dangerous for these patients; both raising the risk of heart attacks and stroke and also having no benefit for behaviour. From 2004 onwards official bodies warned they should be only used as a last resort and only briefly. Doctors ignored the warnings and by 2008 there were about 200,000 elderly patients a year in the UK being prescribed antipsychotics. A Department of Health enquiry in 2009 found prescribing was excessive, not evidence based and that the drugs had contributed to the deaths of 1800 Alzheimer’s patients a year.

It was this scandal, among others, that I debated, with the respected academic. I asked if he thought it curious that while there had been dozens of courts cases and huge fines for illegal off-label prescribing of antipsychotics in the USA, there had not been a single case brought in the UK. Not in the least, he said. There was no illegal off label promotion here; doctors did when it was the right thing to do.  Even though, I asked, all the evidence showed that giving dementia patients antipsychotics was neither safe nor effective? At this point I was accused of forcing companies to put up prices.

Finding refuge in the First Amendment

Astonishing as I found the academic’s blithe denial there was anything wrong, I was even more gob-smacked to discover that the drug companies have come up with a remarkably wizard wheeze to get all this costly legal interference with drug promotion off their backs. They have mounted several legal challenges to prosecutions claiming that FDA (the American drugs watchdog) regulations against off-label promotion “infringed (a salesman’s) First Amendment right of free speech and were therefore void.”

Recently one of these challenges was successful, the judges decided that the rules against off-label prescribing didn’t allow the “free flow of information that would result in a full vetting of the uses, limitations and side-effects of the drug.” My academic sparring partner might find this a believable description of how drug company reps work. I know it is very far from the case. The legal arguments here will run and run, which will certainly benefit lawyers if no one else (pushing up NHS drug prices in the process??).

Off –label prescribing is a murky area that by definition isn’t evidence based. However no one in the UK seems remotely interested letting any sunshine in and neither unconvincing legal wrangling involving free speech nor the ostrich-like activity of senior medics is going to do anything to clarify it.

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