The astonishing tale of infant liver disease, a drug that could save sufferers, and a crooked EC department.
Children suffering from a rare liver disease are unable to benefit from a life-saving treatment because the European Commission on Health in Brussels has rejected a product’s marketing authorisation for the last five years. Orphacol – a medicine for treating youngsters born with otherwise fatal genetic disorders – has been denied European Union-wide approval for inexplicable reasons. But the presence of pharmco bribery in the case is becoming increasingly obvious.
Although the derivative-dividing chaps on Wall Street and the Square Mile have now won the Lonsdale Badguy Belt five years in a row, before then the title was dominated by the pharmco snake-oil salesmen: the other-worldly beings who bribe doctors, cut corners, falsify field results, and then deny responsibility when people start growing extra heads. The things that matter in this world are money, health and housing, but when it comes to sociopathy, there’s not a lot to choose between bankers, pharmcos and estate agents.
‘Ethical pharmaceuticals’ has always struck me as an odd term (it means the stuff you can’t get over the counter, or ‘OTC’) but it is what the pharmboys call the
toxic cocktails drugs they sell into government and the primary care/hospital sectors. It takes a long time and a huge amount of money to develop an effective drug, and so it makes sense that, once developed and launched, the companies behind them want to maximise ROI. They do this by selling chiefly to functionaries and GPs with little or no commercial perspective, and this delivers the sort of mouth-watering margins the rest of us can only have fantasies about. Unfortunately, the process gives the pharmcos a moral hazard in relation to both lobbying and human suffering. This they embrace with open arms and wallets at every suitable turn.
For pharmaceutical marketing people, organisations like the NHS and the EU represent giant orgasmotrons there solely for the purpose of creaming off unfeasible margins and creaming their jeans. A wet dream at Eli Lilly probably consists of civil servants waving blank cheque books around, as all over the floor lie hundreds of people choking to death and covered in pustules. In the foreground, nursing staff in fishnet stockings beg the lucky dreamer to cure all these unhappy patients and, on receipt of the cheque, he dispenses pills to all and sundry. The dead get up and walk, the nurses tear his clothes off, and the bonuses just get bigger and bigger.
In real life, however, it isn’t really like that at all. In the dog-eat-dog business of curing people, only those strong enough to lie every day, and rich enough to bribe every civil servant, will survive to launch the next thalidomide. This means using money and bent test results to rubbish the competition and, if all else fails, buy it. A case in point at the moment concerns the drug Orphacol, and the inability of anyone inside the European Commission apparatus to say no to brown paper bags fully of rapidly inflating fiat currency.
For over three years now, the EC’s commissars have fought a vanguard, rearguard and mudguard action against the small French laboratory CTRS, which developed and markets Orphacol – easily the most effective dug against infant liver disease. The EC condemned children to die by doing so – despite the unanimous advice of experts in all 27 member states that the drug is extremely effective in treating liver diseases. In the case of more rare versions of liver damage in fact, Orphacol is the only hope for sufferers: without it they will expire in tragically short order.
“Buy me or you’ll die” is one of those advertising claims you just instinctively know is going to work. But when it’s the competition that owns it, and not you, then it can be a serious obstacle in the way of cashflow. The brown bags have to get bigger, and the lobbying louder. Following such a campaign by a US pharmaceutical giant, Orphacol still finds itself inexplicably sidelined – so much so that, intrigued by EC intransigence, members of the European Parliament’s Committee on the Environment and Public Health (ENVI) asked the European Commission to present explanations on 21 June last. French MEP Gilles Pargneaux thinks there is no enigma here: a US competitor, he alleges, is working the Commission from behind. “All the clinical arguments [presented by the Commission] are developed word for word by the competitor”, he says (and he’s right) while he adds that he has “evidence that the Commission contacted the competitor directly….I do not want to believe in a conflict of interests in the Commission, but I have strong suspicions”, he told Europolitics. There goes that pesky moral hazard again, spending the taxpayers’ money, tch tch.
The US drugco concerned is called Asklepion Pharmaceuticals, which oddly enough has also requested an authorisation to market a competing drug. However, the drug doesn’t exist as such just yet. The Commission doesn’t even have any details of either the formulation or drug trials involved with ‘the competing drug’. Meanwhile, with every month that bribery holds sway in Brussels, patients are dying needlessly.
On 4th July 2012, an EU General Court convened to hear evidence in the Orphacol case overturned the EC’s refusal to authorise, and ordered it to pay costs. But as of last December, the drug is still being resisted by the Commission. Two names are key to an understanding of why: John Dalli, and his understudy Patricia Brunko.
European Commissioner for Health and Consumer Policy John Dalli justified the refusal on the grounds that clinical trials had not been conducted. This is something of a homaeopathic excuse, given that CTRS has been marketing the drug to enormous applause in France since 1991. But in October, Dalli was sacked by Commission President José Manuel Durão Barroso following suspected corruption involving the tobacco lobby.
As for his ‘friend’ Patricia Brunko, head of a unit responsible for drugs designed for human use within the EU’s Directorate General for Health and Consumers, the French paper Liberation described her recently as ‘determined to sink Orphacol’. Yet another EC spokesperson Aikaterini Apostola released this bollocks to the media last month:
“Marketing authorisations for medicines can only be granted in the EU if the efficacy and safety of the product has been demonstrated according to strict standards. Orphacol did not comply because the applicant tried to short-circuit the requirements needed for obtaining a marketing authorisation”.
This is simply untrue, but now the CEO of CTRS Dr Antoine Ferry has no choice but to go back to the European Court to seek an annulment of the latest denial. “I am sure the commission thought that we would give up the fight, a small company like us. But I am not giving up. We will fight until the end for the wellbeing of patients throughout the EU” he told reporters last month.
But Antoine will have to get his skates on. Asklepion Pharmaceuticals has since submitted its own European Medicines Authority application. It’s being fast-tracked. Success will mean they have the field to themselves for ten years. And more patients will die.