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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Why do the words “soup, swoop, loop de loop” come to mind every time I lift a spoon to my lips?

It’s all thanks to Barry and Anita.

A while ago I was lending a friend the keys to our house. We keep spare keys in a ceramic pot I was given years ago by someone who made it while on an art-school pottery course. “That’s er . . . quite challenging,” the friend said of the pot.

“Is it?” I replied. “I’d stopped noticing how ugly it is.”

“Then it’s a grunty,” she said.

“A what?” I asked.

“A grunty. It’s something you have in your house that’s hideous and useless but you’ve stopped noticing it completely, so it’s effectively invisible.”

I was much taken with this idea and realised that as well as “grunties” there are also “gruntyisms”: things you say or do, though the reason why you say or do them has long since been forgotten. For example, every time we drink soup my wife and I say the same thing, uttered in a strange monotone: we say, “Soup, swoop, loop de loop.” How we came to say “soup, swoop, loop de loop” came about like this.

For a married couple, the years between your mid-thirties and your late forties might be seen as the decade of the bad dinner party. You’re no longer looking for a partner, so the hormonal urge to visit crowded bars has receded, but you are still full of energy so you don’t want to stay in at night, either. Instead, you go to dinner parties attended by other couples you don’t necessarily like that much.

One such couple were called Barry and Anita. Every time we ate at their house Barry would make soup, and when serving it he would invariably say, “There we are: soup, swoop, loop de loop.” After the dinner party, as soon as we were in the minicab going home, me and Linda would start drunkenly talking about what an arse Barry was, saying to each other, in a high-pitched, mocking imitation of his voice: “Please do have some more of this delicious soup, swoop, loop de loop.” Then we’d collapse against each other laughing, convincing the Algerian or Bengali taxi driver once again of the impenetrability and corruption of Western society.

Pretty soon whenever we had soup at home, Linda and I would say to each other, “Soup, swoop, loop de loop,” at first still ridiculing Barry, but eventually we forgot why we were saying it and it became part of the private language every couple develop, employed long after we’d gratefully ceased having soupy dinners with Barry and Anita.

In the early Nineties we had an exchange student staying with us for a year, a Maori girl from the Cook Islands in the southern Pacific. When she returned home she took the expression “soup, swoop, loop de loop” with her and spread it among her extended family, until finally the phrase appeared in an anthropological dissertation: “ ‘Soup swoop, loop de loop.’ Shamanistic Incantations in Rarotongan Food Preparation Rituals” – University of Topeka, 2001. 

This article first appeared in the 21 July 2016 issue of the New Statesman, The English Revolt