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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Work with us: Wellcome Scholarship at the New Statesman

Be one of our 2016 science interns.

Britain needs more great science writers – particularly from backgrounds which have been traditionally under-represented in the media.

To address this, the New Statesman and Wellcome Trust, in partnership with Creative Access, have come together to offer annual placements to student or graduates from an ethnic minority background*.

The final 2016 placement will take place this Autumn/Winter (the exact date is flexible) and will last for four weeks.

Over the course of the placement, the successful applicants will:

  • Work alongside the New Statesman web and magazine team, learning about the editorial and production process, and how articles are conceived, written, edited and laid out;
  • Undertake a data-driven journalism research project on a scientific topic, which will be published on the New Statesman website
  • Visit Parliament and learn about how science-based legislation is developed and debated in the select committee system
  • Have an opportunity to interview a leading scientist or policy-maker
  • Write a regular bylined science blog on the New Statesman website
  • Receive regular feedback and editing from the editorial team
  • Meet journalists at other titles in the sector (previous Wellcome Scholars have met writers for the Atlantic, and presenters for the BBC)

Over the course of the placement, you will be paid London living wage.

To apply for the placement, follow the steps below and apply direct to the New Statesman. 

Please write an 800-word blogpost on a recent or upcoming scientific development which you feel has the potential to change lives significantly, explaining clearly and concisely what stage the research is at, and how it is likely to proceed. It should be written as if for the NS audience - interested, intelligent laypeople.

Please also write up to 200 words on why you are right for this placement and what you would hope to get out of it. You don't need to send a CV.

Please only use Word files, or paste your text into the body of an email. 

Send your application by email to Helen Lewis (Helen @ newstatesman co uk) with the subject line “Wellcome Scholarship 2016”. 

Applications close on 30 September 2016. Interviews will take place soon after.

This is a positive action scheme under the Race Relations Act.