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

BBC/YouTube screengrab
Show Hide image

Why hasn’t British Asian entertainment built on the Goodness Gracious Me golden age?

It is 20 years since the original radio series of Goodness Gracious Me aired. Over two decades, the UK media portrayal of Asians hasn’t used its success to evolve.

Save for a handful of special one-off episodes, Goodness Gracious Me hasn’t occupied a primetime TV slot for nearly two decades. Yet still it remains the measuring stick for British Asian comedy.

The sketch show, which transitioned seamlessly from radio to screen (it started as a BBC Radio 4 series in 1996), has stood the test of time and is as much a staple of modern British Asian culture as Tupperware or turning up an hour late.

What Goodness Gracious Me did so expertly was to take a set of serious issues facing first, second and now, I suppose, third generation migrants, and turn them on their heads. 

In making light of the pressures of academic expectation or family drama, Goodness Gracious Me wasn’t playing down the poignancy of such concerns; it was raising awareness and combatting their uglier side with humour.

It offered resonance and reassurance in equal measure; it was ok to have an embarrassing uncle who insisted he could get you anything much cheaper, including a new kidney, because other people like you did too.

That Goodness Gracious Me was broadcast on a mainstream channel was also a victory for minorities; it made us feel integrated and, perhaps more importantly, accepted. Against the backdrop of Brexit, what wouldn’t we give for that treatment now?

Really, though, the jewel in Goodness Gracious Me’s crown was its willingness to recognise diversity within diversity. It is a relic of a departed era when discourse on TV around Asians was different, when the broad church of that term was truly represented, rather than reduced to one catchall perception of British Muslims.

Goodness Gracious Me offered insight into the experiences and idiosyncrasies – religious or otherwise – of Indians, Pakistanis, Bangladeshis, Sri Lankans and even English people. It’s what made it so accessible and, in answering why subsequent programmes have failed to reach similar heights, this is a good starting point.

Without the flexible sketch format, the modern Asian sitcom Citizen Khan has struggled to cover multiple topics, and, by being specifically about a Muslim family, it leaves many non-Muslim Asians wondering: where’s ours?

I hasten to add that I feel plenty of sympathy for the British Muslim community, hounded by tabloid headlines that attack their faith, but it would be disingenuous to suggest that non-Muslim Asians are sitting pretty in 2016 and don’t need a similar level of support in terms of positive public perception.

The current volume of British Asian media products is fairly good. The BBC has its dedicated network, The Good Immigrant essay collection was one of the outstanding reads of the year, and we still have champions of comedy in Romesh Ranganathan and Nish Kumar.

But I think ultimately it comes down to the broadness of appeal, rather than the quantity of products. Goodness Gracious Me was not only able to engage the full spectrum of British Asia; it transcended its target audience and was on terrestrial TV.

The British Asian media on offer now is up against it, released as the country’s attitude towards foreigners completes a full circle back to the same suspicion my grandfather encountered in the Sixties.

Fewer outlets are willing to explore the stretch of what it means to be Asian, either by denying it due consideration in mainstream shows or by peddling their own monolithic observations. The BBC Asian Network, for example, is laudable in its existence, but does little to engage the young Asians who aren’t into techno spliced with Bhangra.

The mainstream representations of Asians in Western film and television that are commissioned, meanwhile, are irritatingly limited and sometimes inaccurate. In an article for the Guardian last year, Sara Abassi lamented the disproportionate appetite for “gritty post-9/11 films about conservative Pakistani families”, and that the researchers of American series Homeland failed to realise that the national language of Pakistan isn’t Arabic.

When I interviewed the actor Himesh Patel for the No Country for Brown Men podcast, he suggested that the answer to re-establishing Asians in mainstream media, both here and in America, was three-fold. The first challenge to overcome was for outlets to acknowledge that not all Asians fit the same religious or cultural profile; the second was to be open to placing Asians in non-Asian specific products to better reflect their presence in society.

Patel, who is best known for his portrayal of Tamwar Masood in the soap opera EastEnders, made his third recommendation based on this role. He felt that characters should be written with only their personality in mind, making the ethnicity of the actor who plays them incidental. Tamwar’s awkwardness but underlying kindness, Patel said, was what defined him – not his skin colour.

Goodness Gracious Me, though a primarily Asian show and a comedy at that, actually taught some salient lessons about representation. It succeeded in providing a window into a multiplicity of cultures, but at the same time wasn’t a total slave to the politics of identity – several of the 100-plus characters needn’t have been Asian at all. It was reflexive to the times we lived in and a perfect advertisement for empathy. That is why we still talk about it today.

Rohan Banerjee is a Special Projects Writer at the New Statesman. He co-hosts the No Country For Brown Men podcast.