Drug company sues over off label prescribing

Yesterday the drug company Novartis announced it was taking the NHS to court to protest about  off-label prescribing, that’s when a drug is given to patients even though it doesn’t have a license to treat that particular condition.

“It’s unacceptable to put the safety of patients at risk,” said a spokesperson for the company “though widespread use of an unlicensed treatment when a licensed medicine is available.” Indeed.

In the States companies are fined heavily for promoting the off -label use of drugs. Only recently one company had to cough up a hefty 500 million dollars for doing it. And the company’s name? Step forward ….Novartis.

True the actual offence was a while ago and Novartis claims to have cleaned up its act since then. Even so  the penalties – 422.5 million dollars plus 72.5 million dollars – did involve two different drugs – an anti-seizure drugs and an inhaled antibiotic for cystic fibrosis. And while the illegal promotion of the epilepsy drug took place between 2000 and 200,  the other occurred between 2001 and 2006. So, a bit of a serial offender.

What is annoying Novartis about the NHS is that the company has an expensive drug called Lucentis, used to treat macular degeneration, a major cause of blindness, which costs about 740 pounds for each injection. However there is another very similar but far cheaper drug called Avastin that doctors say is just as good and only costs around 60 pounds per injection, so the NHS has been funding its use. However Lucentis is licenced while Avastin isn’t.

Even so wouldn’t it be better to use the drug  that is licenced as it is backed up by clinical trials and so more evidence based? Well yes, but both drugs were developed by Novartis’ partner, a firm called Genentech, and it has long been known that they have a similar effect. Yet despite requests by patient groups and clinicians to run trials comparing them, the company has always refused. Not exactly in the interests of those about to lose their sight.

The American fines for off label prescribing raises the question: Why not here? The legal base is a law designed to prevent companies supplying the government from ripping it off. If the American public health providers were getting such a bad deal it deserved punitive fines and compensation are we really certain the NHS got a good one?

The way the FBI gathers the evidence is to pay whistle blowers a proportion of fines eventually levied. The four who provided evidence about the mis-selling of the epilepsy drug eventually shared 25 million dollars. the promise of rewards on that scale should prompt all sorts of revelations.

Footnote: April 19. The Vioxx saga, a classic example of  illegal  marketing, continues to roll on. Last week  Merck was ordered to pay a 321 million dollar criminal fine for improper marketing.  It promoted Vioxx for treatment of arthritis before the drug had a licence for that. Did the NHS get a good deal on Vioxx?

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