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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Meet Anne Marie Waters - the Ukip politician too extreme for Nigel Farage

In January 2016, Waters launched Pegida UK with former EDL frontman Steven Yaxley-Lennon (aka Tommy Robinson). 

There are few people in British political life who can be attacked from the left by Nigel Farage. Yet that is where Anne Marie Waters has found herself. And by the end of September she could well be the new leader of Ukip, a party almost synonymous with its beer-swilling, chain-smoking former leader.

Waters’s political journey is a curious one. She started out on the political left, but like Oswald Mosley before her, has since veered dramatically to the right. That, however, is where the similarities end. Waters is Irish, agnostic, a lesbian and a self-proclaimed feminist.

But it is her politics – rather than who she is – that have caused a stir among Ukip’s old guard. Former leader Paul Nuttall has said that her views make him “uncomfortable” while Farage has claimed Ukip is “finished” if, under her leadership, it becomes an anti-Islam party.

In her rhetoric, Waters echoes groups such as the English Defence League (EDL) and Britain First. She has called Islam “evil” and her leadership manifesto claims that the religion has turned Britain into a “fearful and censorious society”. Waters wants the banning of the burqa, the closure of all sharia councils and a temporary freeze on all immigration.

She started life in Dublin before moving to Germany in her teens to work as an au pair. Waters also lived in the Netherlands before returning to Britain to study journalism at Nottingham Trent University, graduating in 2003. She subsequently gained a second degree in law. It was then, she says, that she first learnt about Islam, which she claims treats women “like absolute dirt”. Now 39, Waters is a full-time campaigner who lives in Essex with her two dogs and her partner who is an accountant.

Waters’s first spell of serious activism was with the campaign group One Law for All, a secularist organisation fronted by the Iranian feminist and human rights activist Maryam Namazie. Waters resigned in November 2013 after four years with the organisation. According to Namazie, Waters left due to political disagreements over whether the group should collaborate with members of far-right groups.

In April 2014, Waters founded Sharia Watch UK and, in January 2016, she launched Pegida UK with former EDL frontman Steven Yaxley-Lennon (aka Tommy Robinson). The group was established as a British chapter of the German-based organisation and was set up to counter what it called the “Islamisation of our countries”. By the summer of 2016, it had petered out.

Waters twice stood unsuccessfully to become a Labour parliamentary candidate. Today, she says she could not back Labour due to its “betrayal of women” and “betrayal of the country” over Islam. After joining Ukip in 2014, she first ran for political office in the Lambeth council election, where she finished in ninth place. At the 2015 general election, Waters stood as the party’s candidate in Lewisham East, finishing third with 9.1 per cent of the vote. She was chosen to stand again in the 2016 London Assembly elections but was deselected after her role in Pegida UK became public. Waters was also prevented from standing in Lewisham East at the 2017 general election after Ukip’s then-leader Nuttall publicly intervened.

The current favourite of the 11 candidates standing to succeed Nuttall is deputy leader Peter Whittle, with Waters in second. Some had hoped the party’s top brass would ban her from standing but last week its national executive approved her campaign.

Due to an expected low turnout, the leadership contest is unpredictable. Last November, Nuttall was elected with just 9,622 votes. More than 1,000 new members reportedly joined Ukip in a two-week period earlier this year, prompting fears of far-right entryism.

Mike Hookem MEP has resigned as Ukip’s deputy whip over Waters’ candidacy, saying he would not “turn a blind eye” to extremism. By contrast, chief whip, MEP Stuart Agnew, is a supporter and has likened her to Joan of Arc. Waters is also working closely on her campaign with Jack Buckby, a former BNP activist and one of the few candidates to run against Labour in the by-election for Jo Cox’s former seat of Batley and Spen. Robinson is another backer.

Peculiarly for someone running to be the leader of a party, Waters does not appear to relish public attention. “I’m not a limelight person,” she recently told the Times. “I don’t like being phoned all the time.”

The journalist Jamie Bartlett, who was invited to the initial launch of Pegida UK in Luton in 2015, said of Waters: “She failed to remember the date of the demo. Her head lolled, her words were slurred, and she appeared to almost fall asleep while Tommy [Robinson] was speaking. After 10 minutes it all ground to an uneasy halt.”

In an age when authenticity is everything, it would be a mistake to underestimate yet another unconventional politician. But perhaps British Muslims shouldn’t panic about Anne Marie Waters just yet.

James Bloodworth is editor of Left Foot Forward

This article first appeared in the 17 August 2017 issue of the New Statesman, Trump goes nuclear