Pharma plays dirty with covert attack on GPs

The pharma industry does not like to directly come out against ideas it knows will hurt its commercial interests – this makes it look bad and can be detrimental when negotiating with governments/ health bodies. So, what it tends to do is covertly use a body which it funds or has managed to get on side to do the dirty work for it.

There are a number of cases where this has happened – one of the more recent being over the new ways in which drugs are to be priced (watch this space for a later blog).

I received one last week, from a PR company, of course, that quite literally stunned me with its vociferous tone and blatant bias.

The group – the European Alliance for Safe Medicines (EAASM) – has been around for a while and was, until last week it seems, focused solely on anti-counterfeiting for branded drugs in the EU.

It is unsurprisingly funded predominately by pharma including Pfizer – the world’s biggest pharma firm – Eli Lilly and Novartis.

Off label

Now, however, it has turned its attentions to off-label prescribing to combat the ‘institutional malpractice’ it feels is in governments allowing the practice.

Off label prescribing is a practice that allows GPs to prescribe a drug for a condition it is not licenced for, even if there is a branded drug that is licenced to treat the condition.

This is predominately about cost, and the report alludes to the most common use of off label prescribing - i.e., the use of Roche’s cancer drug Avastin as an alternative to Novartis/Roche’s wet AMD drug Lucentis.

Wet age-related macular degeneration (AMD) is the leading cause of blindness in the UK for the over 50s and Novartis’s Lucentis is licenced in the EU to treat the eye disease.

However, it costs £10,000 per eye, per patient. Avastin, on the other hand, costs only £250 per eye, per patient and some limited research has suggested it is as safe and effective as Lucentis – this is why nearly half of all UK GPs will prescribe Avastin over Lucentis.

Both drugs are almost identical in their modes of actions (anti-VEGF) and both were originally developed by a biotech firm called Genentech, now a wholly owned subsidiary of Roche. 

So why doesn’t Roche seek its own marketing application for Avastin for use in wet AMD? Because it is the marketing partner of Novartis for Lucentis, meaning it gains a fair share of the £10,000 per eye per patient – it will not be looking to undercut itself by using Avastin.

However, in an unprecedented move, the Department of Health has asked the cost-effectiveness body NICE to look at allowing Avastin to be used off label in this way and trials are ongoing in the US and UK to fully understand its benefit/risk ratio in this context. If successful, both countries will most likely look to use Avastin off label for wet AMD.

Roche/Novartis are not happy.

GMC to make new plans

To further corroborate this, the UK doctors’ regulator the GMC last week announced a consultation on whether GPs should be able to consider cost when prescribing a drug off label – the GMC feels it should as it costs less and, as long as it is safe and effective, will do the same thing for patients that a licenced drug does.

I spoke to the GMC and they told me they are looking to update their guidance as a result of queries from doctors and medical directors, particularly relating to Lucentis/Avastin and the treatment of aged-related macular degeneration.

“The volume and cost of medicines prescribed in the NHS has soared in recent years,” the spokeswoman told me.

“Doctors can make substantial savings for the NHS by following NICE guidance on cost-effective prescribing that could be reinvested for the benefit of patients.”

In a remarkable coincidence, the EAASM suddenly became all concerned about off label prescribing when this consultation was announced.

It has said that off label use will have ‘very serious consequences’ and believes ‘regulatory vagaries and loopholes’ are allowing these practices to continue, which they say will be to the detriment of patients.

On the specific allusion to Lucentis/Avastin, the report implied that using the latter as an off label option could produce ‘horrifying adverse events’, including blindness and an increased risk of stroke.

It does not mention or reference any clinical trials, but refers to a number of unsubstantiated ‘newspaper reports’ detailing these adverse events – we’re not able to check them and, why would we believe a newspaper report over a clinical trial?

We will have to wait until ongoing trials bring back the results, but be under no illusion - it is a downright lie to say that using Avastin can cause blindness and other events when this has not been verified through the proper channels.

This is being said to distort the GMC’s attempt to cut costs and allow GPs a more liberal approach in prescribing and is being done in an underhanded, nasty way by the pharma industry, solely to help protect their commercial interests.

Business as usual then.