PharmaGossip: Evil big pharma: myth or material?

In the US the False Claims Act regulates those who attempt to defraud the government. In the last 20 years, there have been 165 settlements with pharma companies under the Act, and penalties totalling $14.8 billion have been levied.

The Act was originated in 1863 with the defence industry as its target, but has come into its own when dealing with drug manufacturers.

Indeed, this has built up rapidly over time - 75% of the penalties have occurred in the last five years. Significantly, over half of the penalties were paid by just four companies, GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough. The pharmaceutical industry is now the leading payer of penalties under the Act.

Blowing the whistle on pharma fraud

So what have these companies been doing wrong? The largest proportion of penalties was for promotion of off-label prescribing, a criminal offence. At state level, the next most prevalent abuse was defrauding healthcare providers by over-charging. The next question might be, why has there been this escalation of cases in recent years?

It’s interesting to look at the numbers of cases attributed to ‘whistleblowers’. From 1991 to 2000, these accounted for 9% of the total, but from 2001 to 2010, 67% were sparked off by insider knowledge. My suspicious nature leads me to ask how many cases never came to light in the first of these two decades. Is this rise linked to the fact that whistleblowers can now be rewarded, in some cases extremely generously? It makes sense for the government to pay them $1 million when the company is paying billions. But it might be considered that such people stand little chance of getting another job, so need some financial security.

A global problem?

Well you might say, that’s the US and we all know the private system encourages abuses.

Surely nothing like this happens in other countries? Perhaps not quite like this, but Dr Alain Braillon, lately of University Hospital, Amiens, France, has just reminded me about the benfluorex scandal. The drug, a member of the fenfluramine family, was widely promoted for diabetes and also prescribed off-label for weight loss. It was withdrawn from the market in November 2010 because of cardiac side effects, mainly valvular damage. The closely related drug dexfenfluramine (made by the same company Servier) was withdrawn in 1997, yet the French drug regulatory agency AFSSAPS did not monitor the safety of benfluorex, despite having been publicly warned by doctors working in health insurance agencies in 1998.

It is estimated that 2000 patients might have died from its adverse effects.

In the French case, the opprobrium seems to have been diverted to a large extent away from the company, and towards the politicians.

Government ministers both past and present are staring into the spotlight of unwelcome publicity. Yet one has to ask what the manufacturer’s pharmacovigilance department was making of all this. I searched www.servier.com for benfluorex and its trade name Mediator and came up with nothing.

Dodgy science?

So far my focus has been on sales and marketing abuses. The industry has also come under fire for the way it handles R&D.

In 2009 I attended a debate at The Oxford Union, in which several speakers cited well known cases of bias and distortion. I remember Dr Fiona Godlee, then editor of the British Medical Journal, highlighting that the safety database for Vioxx was founded on nine small studies, and that the safety monitoring board was not free of conflicts of interest. I don’t need to remind you of the eventual fate of that drug.