When will big Pharma finally go transparent?

Not quite there yet.

Last week, the pharmaceutical industry moved a stop closer to being more transparent about its raw clinical trial data, or so they would have us believe.

After the Guardian revealed that the pharmaceutical industry was planning on "mobilising" patient’s groups, which the industry partly funds, to lobby on its behalf against increased clinical data transparency measures being worked out by European regulators, pharmaceutical trade bodies in the US and UK, under increasing pressure, announced their own transparency plans.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and its North American equivalent, the Pharmaceutical Research and Manufacturers of America (PhRMA), announced they would make patient level clinical study reports available for all new drugs and new uses of existing drugs to qualified researchers.

However, first the researcher would have to apply to a board of representatives, chosen and appointed by the pharmaceutical industry, detailing their project idea, funding sources, the qualifications of those who will take part and any potential conflicts of interest, including competitive use, before they could receive access to any of the trial data.

This is a breakthrough of sorts from the pharma industry, which has largely been fighting increased transparency of its data amid high profile campaigns from the likes of British physician Ben Goldacre, who wrote "Bad Pharma," which brought the issue to the mainstream.

Is industry going far enough with its transparency proposals to silence its critics? I doubt it. These proposals are much more restrictive than what European regulator, the European Medicines Agency, has proposed. They want to make any documents not restricted by CCI restrictions or protection of personal data (PPD) downloadable from the EMA website. Raw data that raised PPD concerns would be subject to controlled access, such as a legally binding data-sharing agreement.

If committed to transparency, as many pharma companies would have us believe, why not work with EU and US regulators to come up with terms that at least meet them half-way, instead of lobby against them and then, when exposed, jump in quick with a stricter counter proposal?

At present only a fraction of clinical trial data is being made public. Transparency proponents say publishing raw data will allow doctors to make better decisions when prescribing medications and independent scientists will be able to review ALL the data – not incomplete data that can corrupt the overall out come – and check pharma company’s claims about their new medicines. Missing data, despite robust regulatory practises, can lead to serious safety concerns and wasted money.

For example, the UK’s biggest pharma company, GlaxoSmithKline (GSK), who is currently under investigation in China for bribery charges, pleaded guilty in a US court for promoting antidepressants Paxil and Wellbutrin for unapproved uses and for uses for which evidence of potential harm was available.

GSK never made evidence that it had available to those taking the drug or healthcare professionals that showed the drugs could increase suicidal thoughts in some populations. The company also marketed the drugs for attention deficit disorder (ADD), obesity, anxiety, bipolar disorder and sexual dysfunction although they had no evidence it worked for these problems. GSK ended up paying $3bn to settle the case and launched a new online system allowing researchers to request access to anonymised patient level data that sit behind the results of clinical trials.

Pharma industry say publishing raw data could lead to misinterpretation with the potential to cause a health scare, that it is the job of the regulator only to scrutinise clinical data and that they don’t want to risk patient safety or reveal trade secrets to the competition.

"If enacted, the proposals [by European regulators] could risk patient privacy, lead to fewer clinical trials, and result in fewer new medicines to meet patient needs and improve health." Matt Bennett, senior vice-president of PhRMA told the Guardian recently.

All these points should be duly noted and considered when thrashing out transparency measures, but to say they could lead to fewer clinical trials seems like plain fear mongering. The trade bodies’ latest proposals also seem like a somewhat limp attempt at engaging in transparency – its transparency on their terms only, controlled entirely by industry for them to say yes or no, not much different to how it is now.

By co-operating fully with an initiative that has been coming for a long time, and will inevitably come one day soon, the industry has a real opportunity to improve its often negative image, so it can be known instead for all the excellent and vital work it does – it should embrace this opportunity.

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Photograph: Getty Images

Heidi Vella is a features writer for Nridigital.com

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Is defeat in Stoke the beginning of the end for Paul Nuttall?

The Ukip leader was his party's unity candidate. But after his defeat in Stoke, the old divisions are beginning to show again

In a speech to Ukip’s spring conference in Bolton on February 17, the party’s once and probably future leader Nigel Farage laid down the gauntlet for his successor, Paul Nuttall. Stoke’s by-election was “fundamental” to the future of the party – and Nuttall had to win.
 
One week on, Nuttall has failed that test miserably and thrown the fundamental questions hanging over Ukip’s future into harsh relief. 

For all his bullish talk of supplanting Labour in its industrial heartlands, the Ukip leader only managed to increase the party’s vote share by 2.2 percentage points on 2015. This paltry increase came despite Stoke’s 70 per cent Brexit majority, and a media narrative that was, until the revelations around Nuttall and Hillsborough, talking the party’s chances up.
 
So what now for Nuttall? There is, for the time being, little chance of him resigning – and, in truth, few inside Ukip expected him to win. Nuttall was relying on two well-rehearsed lines as get-out-of-jail free cards very early on in the campaign. 

The first was that the seat was a lowly 72 on Ukip’s target list. The second was that he had been leader of party whose image had been tarnished by infighting both figurative and literal for all of 12 weeks – the real work of his project had yet to begin. 

The chances of that project ever succeeding were modest at the very best. After yesterday’s defeat, it looks even more unlikely. Nuttall had originally stated his intention to run in the likely by-election in Leigh, Greater Manchester, when Andy Burnham wins the Greater Manchester metro mayoralty as is expected in May (Wigan, the borough of which Leigh is part, voted 64 per cent for Brexit).

If he goes ahead and stands – which he may well do – he will have to overturn a Labour majority of over 14,000. That, even before the unedifying row over the veracity of his Hillsborough recollections, was always going to be a big challenge. If he goes for it and loses, his leadership – predicated as it is on his supposed ability to win votes in the north - will be dead in the water. 

Nuttall is not entirely to blame, but he is a big part of Ukip’s problem. I visited Stoke the day before The Guardian published its initial report on Nuttall’s Hillsborough claims, and even then Nuttall’s campaign manager admitted that he was unlikely to convince the “hard core” of Conservative voters to back him. 

There are manifold reasons for this, but chief among them is that Nuttall, despite his newfound love of tweed, is no Nigel Farage. Not only does he lack his name recognition and box office appeal, but the sad truth is that the Tory voters Ukip need to attract are much less likely to vote for a party led by a Scouser whose platform consists of reassuring working-class voters their NHS and benefits are safe.
 
It is Farage and his allies – most notably the party’s main donor Arron Banks – who hold the most power over Nuttall’s future. Banks, who Nuttall publicly disowned as a non-member after he said he was “sick to death” of people “milking” the Hillsborough disaster, said on the eve of the Stoke poll that Ukip had to “remain radical” if it wanted to keep receiving his money. Farage himself has said the party’s campaign ought to have been “clearer” on immigration. 

Senior party figures are already briefing against Nuttall and his team in the Telegraph, whose proprietors are chummy with the beer-swilling Farage-Banks axis. They deride him for his efforts to turn Ukip into “NiceKip” or “Nukip” in order to appeal to more women voters, and for the heavy-handedness of his pitch to Labour voters (“There were times when I wondered whether I’ve got a purple rosette or a red one on”, one told the paper). 

It is Nuttall’s policy advisers - the anti-Farage awkward squad of Suzanne Evans, MEP Patrick O’Flynn (who famously branded Farage "snarling, thin-skinned and aggressive") and former leadership candidate Lisa Duffy – come in for the harshest criticism. Herein lies the leader's almost impossible task. Despite having pitched to members as a unity candidate, the two sides’ visions for Ukip are irreconcilable – one urges him to emulate Trump (who Nuttall says he would not have voted for), and the other urges a more moderate tack. 

Endorsing his leader on Question Time last night, Ukip’s sole MP Douglas Carswell blamed the legacy of the party’s Tea Party-inspired 2015 general election campaign, which saw Farage complain about foreigners with HIV using the NHS in ITV’s leaders debate, for the party’s poor performance in Stoke. Others, such as MEP Bill Etheridge, say precisely the opposite – that Nuttall must be more like Farage. 

Neither side has yet called for Nuttall’s head. He insists he is “not going anywhere”. With his febrile party no stranger to abortive coup and counter-coup, he is unlikely to be the one who has the final say.