A controversial hybrid of clinical trial and patient access scheme that has cost well over a half a billion pounds came under furious assault today in the pages of medical journal the BMJ.

The UK’s ‘risk sharing scheme’ was designed to provide patients with access to four drugs for multiple sclerosis. In doing this it has also provoked an almighty row (by medical academic standards at least).

“The annual drug cost of the scheme is reported to be around £50m,” writes one team, led by Christopher McCabe of the University of Leeds. “If an assessment had been completed after the first two years, the NHS could have saved up to £250m already.”

McCabe’s paper claims there are clear conflicts of interest in those overseeing the scheme, which has cost a total of around £350 million.

The background to this is that in 2002 the National Institute for Health and Clinical Excellence (NICE) ruled that four new drugs – three types of interferon beta and glatiramer acetate – were too expensive for the UK’s National Health Service (NHS).

In response the government set up the risk sharing scheme. This was based on a reasonably simple idea: the NHS would pay for the treatments and those receiving them would be monitored. If the drugs didn’t work, a price review would be triggered and their cost would come down.

That was the theory.

Last year the first review of the scheme was published and, far from doing better, patients on the expensive drugs seemed to do worse than people who weren’t treated. Nevertheless, the study said “it is too early to reach any conclusion about the cost effectiveness of disease modifying treatments from this first interim analysis”.

Today, five papers in the BMJ examine that issue none to gently.

For the prosecution, McCabe’s team examine the reasons given for the delay and find them all lacking. They point out that all those in charge of governance for the risk sharing scheme – the drug manufacturers, patient groups, clinicians and the Department of Health – have “a vested interest in maintaining the status quo”.

Joining the attack is James Raftery, a health technology assessment expert from the University of Southampton, who says the whole thing has been “a costly failure”.

“The biggest losers are the other NHS patients who would otherwise have benefited from the money spent on the scheme,” he writes.

George Ebers, of the University of Oxford, also takes up this point, suggesting an independent inquiry might be in order.

Fighting back is Alastair Compston, of the University of Cambridge. Compston says the other papers are “shrill cries” and that the scheme “achieved what was intended”.

Although he admits that its governance was probably not adequate, he says, “Regardless of the scheme’s outcome, it has advanced the situation for people with multiple sclerosis.”

This utilitarian point is taken on by Neil Scolding, of Frenchay Hospital in Bristol. He points out that the scheme has led to the creation of a network of MS care including 250 specialist nurses. “If the scheme—expensive and flawed, as Professor Ebers points out—turns out to have been no more than a clever wooden horse, then the army of multiple sclerosis healthcare specialists it delivered may make it more than worthwhile,” he writes.

Of course, this rather ignores Ebers and Raftery’s points about the opportunity costs.

As Karl Claxton, one of the authors on McCabe’s paper, asked me rhetorically when I was writing a feature on NICE (in a different context but about the same fundamental issue): “what about the people whose health care gets displaced because of the cost?”