The pharmaceutical industry is cleaning up its act but more needs to be done to open up trial data for the public.
This is according to last night’s PharmaTimes debate at the Royal Institution, which saw Dr Ben Goldacre, author of Bad Science and Bad Pharma go head-to-head with the chief executive of the Association of the British Pharmaceutical Industry Stephen Whitehead, on the motion: Pharma is not getting its act together.
Whitehead deplored the title of the debate as “an insult”, describing the campaign waged against the industry over these issues as “a travesty of the truth”, he said.
“Patients believe the drugs they are given are not adequately tested – this is just not true,” he said. Regulators see “every scrap” of data as part of the approval process, but none of them has issued a single comment in the debate on transparency, he pointed out.
“We agree that summary clinical trial evidence should be available publicly, and we are committed to greater transparency, but what is at issue is how we get there – it’s not the ‘what’, it’s the ‘how’,” he said.
Goldacre said the industry and its stakeholders now have a unique opportunity to address the vital issue of transparency. “I’ve tried to engage the public in a problem that we’ve failed to fix behind closed doors”, he said, and there is now a growing campaign, backed by politicians, the Medical Royal Colleges – and with patient groups leading the way – and he urged the industry to recognise that “this is right”.
On pharma’s radar
Trial data transparency has been a simmering topic on pharma’s radar for some time. The European Union is currently revising the Clinical Trials Directive (2001/20/EC), and proposed regulation, published by the European Commission last July, would require sponsors to submit a “summary of results” to the EU’s clinical-trial database within one year of a clinical trial ending.
However, ever since the launch of Ben Goldacre’s controversial book Bad Pharma last year, the pharmaceutical industry has received an increased amount of scrutiny. Roche in particular has been in the spotlight over unpublished Tamiflu results, which it has repeatedly refused to provide, until November last year, when the company announced it was considering releasing the complete raw dataset. The UK Government has also waded in on the debate with plans to investigate the industry over its tendency to withhold data.
Meanwhile, in January this year, Goldacre, along with the BMJ, the James Lind Initiative, and the Centre for Evidence-Based Medicine, launched the AllTrials initiative, which calls on governments, regulators and research bodies to put in place measures ensuring that “all trials past and present” are registered and “the full methods and the results” reported. GlaxoSmithKline and NICE have both signed up.
However, Whitehead said the industry “will not respond to PR-driven initiatives such as AllTrials”, and despite GSK signing up to the initiative, the ABPI has said it won’t follow suit because of public concerns over preserving patient anonymity. Ensuring this would be a huge undertaking, said Whitehead, and he wondered whether the cost of doing so would justify the benefit for drugs that have been on the market for a very long time.
Individual patient data would be redacted from the trial information, said Goldacre, but clinical quality assurance expert Dr Beat Widler, supporting Whitehead, warned that, with social media, it can be relatively easy for some patient information to be traced back to the individual. “We must make results available but in a sensible way that doesn’t make things worse. We need to understand what can go wrong,” he cautioned.
ABPI needs to lead
Dr Fiona Godlee, editor-in-chief at the BMJ and a panellist at the event, asked what the alternative was to transparency. “In the end, we must have independent scrutiny,” she argued, adding that the ABPI “needs to show leadership. The public would be very disappointed if the NHS is given anything but the best information available to patent holders on drugs”.
Godlee also emphasised that calls for greater transparency did not threaten pharma and would bring it benefits such as a level playing field, less waste of resources, no more “good guy/bad guy” and the chance to have “a grown up conversation with the public”.
However, Stephen Whitehead said the ABPI had been “working on data release for the past 10 years, but monitoring and compliance was needed to achieve ‘Good Pharma’”.
Whitehead also dismissed Goldacre’s claim that only 50% of all trial data was ever published, arguing that this was “historical”, and it was in fact closer to 78% – according to data he received from the FDA, while figures for the European Union covering 2010 and 2011 suggest a similar percentage, he said.
Even a Roche representative in the audience spoke up saying: “Roche is listening. We could be more active; that’s why we are here [at the PharmaTimes debate] tonight.” This morning the Swiss firm announced new trial transparency measures, as covered on PharmaTimes World News.
Final vote
In the final vote of the night, exactly a quarter of the 400 plus audience agreed with the premise of the night that pharma was not getting its act together, with 9% saying they strongly agreed. However, 39% disagreed with the statement, and 19% strongly disagreed.
The debate had not shifted attitudes too dramatically, as this question was put to the audience before the speakers took to the stage, and the numbers remained largely similar. The biggest difference were for those who were sitting on the fence: in the first vote 22% said they neither agreed not disagreed with the statement, while only 7% said the same after the debate.
PharmaTimes would like to thank our sponsors for the event, Binley’s.
Voting results
Pharma is not getting its act together (initial vote prior to debate)
7% strongly agree
26% agree
21% neither agree nor disagree
35% disagree
11% strongly disagree
Pharma is not getting its act together (second vote after the debate)
9% strongly agree
25% agree
7% neither agree nor disagree
39% disagree
19% strongly disagree
I trust politicians to make the NHS better rather than worse
3% strongly agree
12% agree
11% neither agree nor disagree
40% disagree
33% strongly disagree
I trust healthcare managers to serve the best interests of patients rather than their political masters or payers
1% strongly agree
14% agree
17% neither agree nor disagree
48% disagree
19% strongly disagree
I trust clinical staff not to harm me, and to offer me the best treatment available for me
5% strongly agree
45% agree
22% neither agree nor disagree
21% disagree
7% strongly disagree
All results from all trials for all treatments currently in use must be publicly available
36% strongly agree
33% agree
10% neither agree nor disagree
16% disagree
5% strongly disagree
I trust the pharmaceutical industry to make all results from all trials for all treatments currently in use publicly available
5% strongly agree
15% agree
18% neither agree nor disagree
43% disagree
19% strongly disagree
Avoidable harm and sub optimal care are endemic in healthcare
13% strongly agree
40% agree
21% neither agree nor disagree
21% disagree
4% strongly disagree
If I encountered unethical behaviour in my organisation, I would speak up and be confident I would not be punished, my concerns would be properly investigated and appropriate action taken to protect patients
36% strongly agree
28% agree
18% neither agree nor disagree
13% disagree
5% strongly disagree
Drug A and drug B have equal efficacy. Drug A’s data is fully disclosed, drug B’s data is partially disclosed. I would choose drug A.
44% strongly agree
23% agree
24% neither agree nor disagree
7% disagree
3% strongly disagree
I trust the Cochrane Collaboration to use our data fairly
24% strongly agree
39% agree
19% neither agree nor disagree
14% disagree
3% strongly disagree
The regulators are working
5% strongly agree
45% agree
24% neither agree nor disagree
21% disagree
5% strongly disagree
Open access will improve adherence
7% strongly agree
23% agree
16% neither agree nor disagree
37% disagree
16% strongly disagree
