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.

Folllow Heidi on Google plus here

Photograph: Getty Images

Heidi Vella is a features writer for Nridigital.com

Getty
Show Hide image

Banishing safe seats, and other proposals to bridge the democratic divide

How to improve key areas of democracy.

Labour’s election train is finally pulling into the station, with its new leader announced in just over a fortnight. However, a summer absorbed in the party’s internal democracy has obscured a deeper truth confronting the country: the general election confirmed that unequal political participation rates in the UK – by age, class, ethnicity and region– have become increasingly hardwired into how our democracy operates.

IPPR’s new report underscores the scale of the democratic divide.  For example, less than half of 18-24 year olds voted, compared to nearly four-fifths of the over-65s, while three-quarters of "AB" individuals cast a ballot, against just over half of "DE" registered voters. Critically, this marks a sharp rise in turnout inequality over time. In 1987, for example, turnout rates by class were almost identical but have steadily diverged since.

Similarly, age-based differences have got significantly worse over time. In 1964 turnout for 18-24 year olds was 76.4 per cent, almost matching the 76.7 per cent turnout rate of those aged 65 or over. By 2005 only 38.2 per cent of 18-24 year olds voted against 74.3 per cent of 65+ year olds, with only a very slight improvement this year.

Underlying growing disparities of electoral voice are striking divergences in perceptions of the fairness and effectiveness of our democracy. For example, IPPR/YouGov polling suggests a striking 63 per cent of "DE" individuals think that our democratic system serves their interests badly, while "AB" voters are evenly split.

Given these signs of democratic distress, there remains a strong case for establishing a wide-ranging constitutional convention to reset how our democracy operates. Yet Westminster shows no appetite for such constitutional reformation, and there would only be so much a civil society-led convention could achieve in terms of practical change.

In our report we therefore propose a series of achievable reforms that could update the civic, institutional and technological architecture of our democracy in the here and now, with the explicit goal of ensuring that all voices are better heard in the political process.

On electoral reform, while we reiterate our support for proportional representation for national elections, we know this simply isn’t going to happen this Parliament. We had a referendum on change in 2011 and it was heavily lost. The energies of electoral reformers should therefore focus on extending PR in local government, where it is more obviously in the self-interest of the major parties, as a means of extending their geographical reach.

In addition, the reduction in the number of MPs provides an opportunity to chip away at the number of safe seats. More than half of seats are "safe", a number that has grown over time, even allowing for the electoral earthquake in Scotland. Safe seats typically have lower levels of participation, lower turnout rates, and less electorally powerful voters. While safe seats will always be with us in a first-past-the-post system, too many can be damaging to democracy.

Given this, we have recommended that the various Boundary Commissions of the UK be given a new duty to consider the electoral competitiveness of seats – ie. to tilt against the creation of safe seats – when boundaries are redrawn. The priority would be to meet their current duties of ensuring the geographic coherence of a seat and roughly equal electorates.

However, where these duties can be met we suggest that the Commissions should consider revising boundaries to reduce the number of safe seats, as a step to increasing participation and the voting power of the average elector. Of course, this will clearly not "abolish" all safe seats – nor should it  but it could help re-empower millions of voters currently with little meaningful say over the outcome of elections and force political parties to up their game in safe seats.

At the same time, the transition to the individual electoral registration process risks excluding millions from the franchise, people who are disproportionately younger, poorer or from an ethnic minority. For example, there are clear inequalities by age and ethnicity in terms of who is registered to vote: in the 2010 general election, for which figures are most accurate, 90 per cent of people aged 55-64 were registered, compared to 55 per cent of those aged 18-24, while nearly 20 per cent of BME individuals were not registered to vote, compared to only 7 per cent of the "white British" population.

There are simple steps the government could take to ensure all who are eligible are able to vote: extending the registration deadline to December 2016, and making support available to local authorities to assist registration efforts, weighted towards authorities with higher levels of under-registration, could help reduce inequalities.  In the longer term, electoral registration officers should be given new duties, and the Electoral Commission more powers, to drive up registration rates, with a particular focus on presently under-registered demographics. 

Finally, we recommend introducing a Democracy Commission. At present, the Electoral Commission effectively regulates elections and party funding. Democracy, however, is far richer and broader than electoral processes. It is about formal representation, but also about participation and deliberation, in what Marc Stears has called "everyday democracy".

A statutorily independent Democracy Commission could give institutional ballast to the latter and help reinvigorate democratic life by providing research, resources and capacity-building to facilitate local, civil society-led initiatives that aim to increase broad-based levels of powerful democratic participation or deliberation in collective decision-making processes.

For example, a Democracy Commission could work with the GLA to introduce participatory budgeting in London, assist the Greater Manchester Combined Authority in instituting a public deliberative body with real teeth over how to integrate health and social care in the area, help the Scottish government conduct citizens’ juries on the future constitutional shape of the country, or support civil-society experiments to bring people closer to collective political decision-making processes in their locality.

We are living in a paradoxical political era, where growing political inequality is accompanied by ongoing social and technological change that has the capacity to collapse unnecessary political and economic hierarchies and build a more inclusive, participatory and responsive democracy. However, there is no guarantee that the age of the network will necessarily lead to democratic revival. The institutions and technologies of our political system, products of the 19th century, are struggling in the fluidity and fracture of the 21st century, inhibiting democratic renewal.

With our economy post-industrial, our ways of communicating increasingly digital and more networked, our identities and relationships ever more variegated and complex, it is therefore critical public policy seeks to update the democratic infrastructure of the UK, and, in so doing, help reverse entrenched political inequality.

Such an agenda is vital. If we simply accept the current institutional arrangements of our political system as the limits of our ambition, we must also content ourselves to live in a divided – and therefore inherently partial – democracy. Yet our democracy is not immutable but malleable, and capable of being reformed for the better; reform today can make democratic life more equal. After all, the story of British democracy’s evolution is one of yesterday’s impossible becoming today’s ordinary.

Mathew Lawrence is a research fellow at IPPR and the co-author of "The Democracy Commission: Reforming democracy to combat political inequality". He tweets at @dantonshead.