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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It's easy to see where Berlin is being rebuilt – just hit the streets

My week, from walking the streets of Berlin to class snobbery and the right kind of gentrification.

Brick by brick, block by block, the people are rebuilding the city once called Faust’s Metropolis. To see it clearly, put your boots on. One of the most bracing walks starts by the Gethsemane Church, which served as a haven for dissenters in the last days of the GDR and takes you down ­towards the Hackescher Markt.

Here, in what is still the eastern half of a divided city that wears its division more lightly, is a Berlin experience both old and new. In three decades of frequent visits, it has been fascinating to note how much this part of town has changed. Even a decade ago these streets were rundown. With crumbling buildings showing bulletholes, it wasn’t hard to imagine what the place looked like in 1945. Now there are lilacs, blues, and yellows. Cafés, bars and restaurants abound, serving the young professionals attracted to the city by cheap rents and a renewed sense of community.

 

Breaking the fourth wall

Looking north along Schliemannstraße, you’ll find a delightful vista of well-tended balconies. It’s a pleasant place to live, notwithstanding the gaggle of grotesques who gather round the corner in the square. On Kastanienallee, which forms the second leg of the walk, an old city feels young. It’s a kind of gentrification but the right kind. There’s more to eat, to drink, to buy, for all.

Berlin, where Bertolt Brecht staged his unwatchable plays, was supposed to have been transformed by a proletarian revolution. Instead, it has been restored to health by a very middle-class one. Germany has always had a well-educated middle class, and the nation’s restoration would have impossible without such people. The irony is delicious – not that irony buttered many parsnips for “dirty Bertie”.

 

The new snobbery

The British Museum’s survey of German history “Memories of a Nation” is being presented at the Martin-Gropius-Bau as “The British View”. Germans, natürlich, are curious to see how we observe them. But how do they see us?

A German friend recently in England  said that the images that struck him most forcibly were the tins of food and cheap booze people piled up in supermarkets, and the number of teenage girls pushing prams. Perhaps Neil MacGregor, the former director of the British Museum who will shortly take up a similar role here at the new Humboldt Forum, may turn his attention to a “German View” of the United Kingdom.

There’s no shortage of material. In Schlawinchen, a bar that typifies Kreuzberg’s hobohemia, a college-educated English girl was trying to explain northern England to an American she had just met. Speaking in an ugly modern Mancunian voice that can only be acquired through years of practice (sugar pronounced as “sug-oar”), she refer­red to Durham and York as “middle class, you know, posh”, because those cities had magnificent cathedrals.

When it comes to inverted snobbery, no nation can match us. To be middle class in Germany is an indication of civic value. In modern England, it can mark you as a leper.

 

Culture vultures

The Humboldt Forum, taking shape by the banks of the Spree, reconsecrates the former site of the GDR’s Palace of the Republic. When it opens in 2018 it will be a “living exhibition”, dedicated to all the cultures of the world. Alexander von Humboldt, the naturalist and explorer, was the brother of Wilhelm, the diplomat and philosopher, whose name lives on in the nearby university.

In Potsdamerplatz there are plans to build a modern art museum, crammed in between the Neue Nationalgalerie and the Philharmonie, home to the Berlin Philharmonic. Meanwhile, the overhaul of the Deutsche Staatsoper, where Daniel Barenboim is music director for life, is likely to be completed, fingers crossed, next autumn.

Culture everywhere! Or perhaps that should be Kultur, which has a slightly different meaning in Germany. They take these things more seriously, and there is no hint of bogus populism. In London, plans for a new concert hall have been shelved. Sir Peter Hall’s words remain true: “England is a philistine country that loves the arts.”

 

European neighbours

When Germans speak of freedom, wrote A J P Taylor, a historian who seems to have fallen from favour, they mean the freedom to be German. No longer. When modern Germans speak of freedom, they observe it through the filter of the European Union.

But nation states are shaped by different forces. “We are educated to be obedient,” a Berlin friend who spent a year at an English school once told me. “You are educated to be independent.” To turn around Taylor’s dictum: when the English speak of freedom,
they mean the freedom to be English.

No matter what you may have heard, the Germans have always admired our independence of spirit. We shall, however, always see “Europe” in different ways. Europe, good: we can all agree on that. The European Union, not so good. It doesn’t mean we have to fall out, and the Germans are good friends to have.

 

Hook, line and sinker

There are fine walks to be had in the west, too. In Charlottenburg, the Kensington of Berlin, the mood is gentler, yet you can still feel the city humming. Here, there are some classic places to eat and drink – the Literaturhauscafé for breakfast and, for dinner, Marjellchen, a treasure trove of east Prussian forest delights. Anything that can be shot and put in a pot!

For a real Berlin experience, though, head at nightfall for Zwiebelfisch, the great tavern on Savignyplatz, and watch the trains glide by on the other side of Kantstraße. Hartmut Volmerhaus, a most amusing host, has been the guvnor here for more than 30 years and there are no signs that his race is run. The “Fisch” at twilight: there’s nowhere better to feel the pulse of this remarkable city. 

This article first appeared in the 01 December 2016 issue of the New Statesman, Age of outrage