GSK and Roche have discussed clinical data transparency in a House of Commons Science and Technology Committee session.

Both companies expressed a commitment to greater disclosure of clinical trial results, acknowledging that public opinion on this issue had changed.

Leading medical academic Dr Ben Goldacre (pictured), author of Bad Pharma, questioned the speakers on how effectively these ideals would be realised by industry.

The issue of access to clinical trial data was highlighted by recent controversy over Roche’s trials of the antiviral Tamiflu, data from which were promised but not delivered to the Cochrane research group.

A campaign for the publication of all clinical trial data was fronted by Goldacre and supported by Cochrane, NICE and the BMA.

In recent months, GSK has pledged to publish all clinical trial data relevant to its currently available drugs, while Roche has promised to make redacted versions of the ‘missing’ Tamiflu trials available to Cochrane.

The Parliamentary session debated the industry’s principles and practices in this contentious area.

James Shannon, GSK’s Chief Medical Officer, said the company would only submit clinical study reports to a regulator if it were applying for a product licence – but “all of those studies would be published in a peer-reviewed journal”.

That might be true for GSK, Goldacre commented, but it was not generally true for the industry.

William Burns, a director at Roche, stated: “What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond.”

Goldacre replied that Roche was “making exactly the right kind of noises” about transparency, but had not yet delivered on its “aspirations”.

Both companies reiterated that they were committed to meeting clinical demands for data transparency.

Most UK pharmaceutical companies will disclose the payments they make to healthcare professionals (HCPs) from 2015 onwards.

ABPI member companies have agreed to publish details of payments made to individuals in fees and sponsorship for training.

As a start, they will shortly publish aggregate totals of payments made to HCPs in 2012, estimated to amount to £40m for the UK pharma industry.

The ABPI said it hoped the greater transparency would not only improve trust but also raise awareness of the benefits to healthcare of industry sponsorship.

From 2016 (covering 2015 figures), ABPI member companies will disclose the payments made to sponsor and support HCPs – for example, paying for them to attend international conferences – as well as fees for advisory and speaker roles.

They will also reveal how many HCPs they have made payments to in each year from 2015 onwards.

The new transparency standards for industry have been developed by the Ethical Standards in Health and Life Sciences Group (ESHLSG), which is seeking to promote partnership between industry and the NHS.

Stephen Whitehead, ABPI Chief Executive, commented: “The industry is proud of its collaboration with healthcare professionals. By publishing these figures industry’s aim is to ensure these vital relationships are open and transparent.

“It is right that professionals are reimbursed fairly for the time and expertise they regularly provide the industry in developing the next generation of medicines. These figures also show another way in which the pharmaceutical industry adds value to the NHS by supporting training and development and medical education.

“It is right that companies are transparent about the support they provide and it is important that we also recognise the benefits this delivers the NHS.”

NICE will be responsible for assessing the value of medicines in the new value-based pricing (VBP) system to be implemented in 2014.

The Government’s decision to make NICE central to VBP follows recommendations by the Health Select Committee (HSC).

It also follows a report by the European Commission stating that NICE’s QALY metric, the basis of its current value appraisals, is unfit for purpose.

The new role in VBP assessment will enable NICE to broaden the scope of its appraisals of the costs and benefits of drugs.

This will simplify the current routine of NICE declaring a drug too expensive in draft guidelines and then revising its verdict when the company offers a confidential patient access scheme.

Health Minister Lord Howe said: “We are delighted to announce the central role NICE will take in assessing the value of new medicines. This will allow us to draw on NICE’s world-leading expertise as we develop the Value-Based Pricing scheme.”

From April, NICE will be led by new Chairman David Haslam (pictured). It will have responsibility for social care as well as the NHS and public health, enabling it to play a major role in the integration of care.

The Government approved three other HSC recommendations: NICE should develop healthcare quality standards for patients with long-term conditions, co-morbidities or complex needs; NICE should promote better-integrated commissioning and care; and industry should be more transparent as regards clinical trial data.

Stephen Whitehead, Chief Executive of the ABPI, commented: “What will determine whether value-based pricing works for the pharmaceutical industry, the NHS and most importantly patients is not who does the assessment, but how it is done and what goes into it.

“NICE has an important role in supporting growth, which is often overlooked. NICE needs to be an enabler of innovation by the NHS and this is lacking from the Government’s response.

“We urge the Government to keep its foot on the pedal in spreading innovation through the NHS and ensuring that NICE helps to deliver its part of the growth agenda.”

Evidence of widespread conflicts of interest among NHS commissioners has prompted calls from the BMA and the Labour Party for tighter regulation.

A BMJ study found that more than a third of GPs on the new CCG boards had a financial interest in private providers of healthcare, either as shareholders or as directors.

The NHS Commissioning Board stated that transparency over potential conflicts of interest would enable CCGs to self-regulate effectively.

Shadow Health Secretary Andy Burnham commented: “There is a real risk that the doctor-patient relationship will be corroded and public trust in the NHS lost.

“At the very least, ministers must bring in new rules to ensure that no GP takes part in any decision in which they could be perceived to have a financial interest.”

The BMA expressed concern that the reputation of GPs was at risk. Laurence Buckman, Chairman of its General Practitioners Committee, said: “In our view, GPs who are directors of, or who have significant financial interests in, companies who might be awarded contracts to provide services should seriously consider their membership of CCG governing bodies. Alternatively, they should consider their position within provider companies.

“We support the principle of greater clinician involvement in commissioning, but it must not come at the expense of the trust of patients.”

According to an NHS Commissioning Board spokesman, “it is vital that everyone working for a CCG or serving on its governing body declares any interests they have. This allows the CCG to put arrangements in place to ensure that those individuals are not involved in any decisions that would give rise to a conflict.”

AbbVie is seeking a legal injunction to block the European Medicines Agency (EMA) from publishing clinical trial data relating to its rheumatoid arthritis drug Humira.

The biopharmaceutical company claims that publishing the trial data would violate both commercial confidentiality and patient confidentiality.

AbbVie’s position contrasts with that of GSK, which has committed to publishing all its future and past clinical trial data, and shows that the pharma industry is becoming polarised on this issue.

The EMA has committed to publish all clinical trial data once a drug has completed marketing authorisation from the start of 2014.

The AllTrials ‘open data’ movement, which GSK now supports, has been driven by medical authorities including the Cochrane Collaboration and the BMA.

The AllTrials position is that secrecy around clinical trial data rewards dishonesty in the planning and reporting of trials, and that transparency is in the interests of all patients and all honest pharma companies.

AbbVie, which recently split off from Abbott, has the support of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in seeking to protect clinical trial data as ‘confidential’.

By preventing the EMA from publishing the clinical trial data relating to Humira (adalimumab), AbbVie seeks to ensure its own right to select which data are available to prescribers and patients.

Sir David Nicholson, Chief Executive of the NHS, could be charged with corporate manslaughter in a private prosecution over Stafford General Hospital.

A member of the public has applied to Camberwell Green Magistrates’ Court for permission to charge Nicholson with corporate manslaughter and misconduct in public office, as well as perverting the course of justice.

Alan Edwards of Greenwich, London, a former investment banker, seeks to convince the court that Nicholson has a prima facie case to answer – i.e. that his guilt is plausible on the known evidence.

Edwards hopes to call on witnesses including members of the Cure the NHS campaign; CQC board member Kay Sheldon and former CQC investigator Heather Wood; and patient groups representing families.

“The regulatory system is just not fit for purpose,” he said. “That is why I am doing this and because there are serious failings across the health system which means things like deaths are covered up.

“We will seek full disclosure of all correspondence with David Nicholson’s office to find out about all of the information he received, what information he had and what he did with that.”

Nicholson has already claimed that the Labour government’s infection control and waiting time targets were responsible for the deaths because they distracted healthcare professionals from care quality.

Legislation allowing prosecution for corporate manslaughter was passed in the UK in 2007.

Private prosecutions for serious crimes are rare in the UK, though precedents exist. It is not clear whether Edwards will be cleared to bring the prosecution.

The Department of Health commented: “We see no basis for this case.”

Doctor and writer Ben Goldacre has upset the ABPI with his claims about the ‘corruption’ of evidence-based
medicine – yet he’s been credited with influencing GSK’s new policy on clinical trial data. In an exclusive interview, Goldacre tells Pf about the good, the bad and the dodgy in pharma.

There’s no getting away from Ben Goldacre. He’s the fast-blogging front man of the AllTrials campaign, which seeks to make the publication of all clinical trials (new or old) relating to drugs in current use an industry and medical norm – in practice, not just in theory. His book Bad Pharma accuses the industry of exploiting weaknesses in medical practice and regulation to distort the evidence base of medicine through biased trials, ghostwritten papers, selective publishing and use of KOLs. He’s calling for a rebuilding of “the information architecture of evidence-based medicine”.

Industry critics in the UK and the US have accused Goldacre of focusing on “historic” issues, failing to back up his assertions with evidence, and “cherry-picking” extreme cases. These claims misrepresent a measured and coherent book that is by no means a hatchet job on the pharma industry. Indeed, Goldacre makes it clear that “there is no medicine without medicines”. His first book, Bad Science, defended the principles of modern medicine against the claims of ‘alternative’ therapies. He describes himself as a “critical friend” of pharma – and GSK might well agree, having signed up to the AllTrials campaign this month.

Goldacre himself is no web-dwelling misfit. He’s a doctor with an M.A. in philosophy and research fellowships in psychiatry and epidemiology. He’s also won the Association of British Science Writers award for best feature, twice. Pf readers may also be interested to note that his father is a professor of public health at the University of Oxford, while his mother is the enigmatic vocalist of proto-Goth 1970s
band Fox.

Pf will review Bad Pharma on its website. Meanwhile, we interviewed Ben Goldacre on his view of the industry. Without pausing to comb his hair, he gave us an entertaining and pointed account of a situation in which “people know that there’s something a little bit wrong”. Can you honestly disagree?

Dodgy data
GSK has announced that it will publish all trial data relating to its current products, with older data being released over several years. Goldacre tells us that he met Andrew Witty, CEO of GSK, before the announcement. “He’d obviously thought very carefully about the practicalities of it, and that reassures me – he’d thought about how to do it, what the costs would be, and I think it’s to his enormous credit.”

None the less, Goldacre says, “what we really need is meaningful structural change where everybody is incentivised and induced and, to an extent, cajoled into doing the right thing. The basics of evidence-based medicine require that we have all of the evidence in order to make informed decisions, and we need that for doctors, not just for regulators.” Still, he notes, even one major company signing up poses the question: “Why is it that GSK are happy for doctors and patients to be able to see all of the evidence on their treatments, whilst other companies aren’t happy with that?”

Bad Pharma did not ‘reveal’ any hidden things, Goldacre insists: “It took very well documented problems in medicine from the academic literature and offered the general public an accessible explanation of those problems, because I feel very strongly that there are various ongoing structural problems in medicine which go way beyond just the pharmaceutical industry. And these problems have not been fixed behind closed doors by the professions, so I think we need the public’s help.” By “the public”, he means the many professionals – lawyers, civil servants, campaigners – who “can bring about structural change”.

The industry’s initial reaction to the book was defensive. “The ABPI put out various things saying that I was a fringe maverick who wasn’t taken seriously by anyone in medicine or academia or by regulators, and I think seeing that led various people to conclude that it was worth creating a more well-structured campaign.”

Stressing a key point, Goldacre notes: “When the public are made aware that drug companies and academics are still entitled to withhold results on medicines that we currently use from doctors and patients, they are amazed and appalled. The ABPI’s press release about my book said that all of the issues in it were historic and had all been long addressed, which is obviously untrue. I think policy makers have to be very concerned about an organisation that is willing to make such sweeping dismissals of legitimate and well documented concerns.

“For the ABPI to state that they were refusing to engage with the concerns that I raised in the book was an extraordinary thing, and it has been well noted throughout the medical and policy communities. I think my views are ultimately reasonably well aligned with those of industry. I would regard myself as a critical friend: I’m talking about problems that need to be fixed.”

Single bed
But surely, and leaving pious pharma rhetoric aside, the industry has to do what it does to get new medicines out there? Goldacre’s response is milder than you might expect. “Medicines work, there’s no question about that. But if you work in the pharmaceutical industry, you might miss how many criticisms of doctors, academics and regulators there are in the book. We invented evidence-based medicine very recently, only three or four decades ago, and since then we’ve all run around pretending that we have instantiated it already. But the reality is, we haven’t.

“I don’t think it’s unreasonable or unrealistic to say that we can manage profit incentive in the pharmaceutical industry in such a way that their goals are more closely aligned with the goals of patients. If you have an incoherent information architecture, lots of opacity around evidence, and regulatory
frameworks that are undoubtedly very onerous for industry, but still fail to achieve very simple objectives like getting doctors all of the evidence on whether drugs work or not, then companies are competing with each other across terrain that actively rewards bad behaviour.

“I’d like to see a world in which companies are all competing across terrain that actively rewards ethical behaviour like sharing all of the data on how well their treatments work. I think it should be perfectly possible to make lots of money out of the best drugs in a class, and if that means that you may not be able to profit from the third best drug in a class to the extent that you can today by obfuscating around the evidence – well, so be it, because I think overall, industry would benefit from clearer information, as doctors and patients would.”

Straight talking
Goldacre sums up the issue: “Industry does one thing that’s really great and one thing that’s not so great. Industry creates new medicines, and that’s fantastic and really important, and it’s obviously to the benefit of doctors and patients. But then there’s this second issue of how doctors and patients make decisions about which treatment is best. And in that arena, the pharmaceutical industry is obviously very conflicted. Each company wants you to use their products, so in an environment where we accept that you can withhold the results of clinical trials and put spin on their results when they’re published in academic journals, it’s inevitable that people will try and do that.”

Much of the blame rests with regulators for decades of underachievement, he argues. For example, “there’s this bizarre idea that it is satisfactory for the EU Clinical Trials Register to be a register of all the clinical trials conducted in Europe. Now that is not actually a very useful list. The Register, were it to be genuinely useful, would be very simply a list of all of the trials ever conducted on all of the medicines that are currently licensed for use in Europe.” That “failure of vision”, he says, speaks volumes about the culture of medicine.

What’s needed, he argues, is for “doctors, governments, healthcare payers and academics” to be “better at creating systems for synthesising evidence, disseminating it to decision makers, and then implementing best practice”. If that were the situation, he says, the “biased dissemination of evidence” that is marketing – and as he fairly points out, that is what marketing has to be – could not weaken clinical outcomes.

Golden ticket
Goldacre offers no support to those who dismiss modern medicine in favour of mystical alternatives. “Just because there are flaws in aircraft design, that doesn’t mean magic carpets exist. The fact that there are problems in medicine doesn’t mean that magic sugar pills work.” However, he argues, the antimedical conspiracy theories “are a kind of poetic response to the obvious regulatory failure in medicine and in the pharmaceutical industry. People know that there is something a little bit wrong here.”

He also separates himself from leftwing critiques of corporate culture. “I don’t have a sense that there’s anything wrong with companies making money from making medicines. I think this is actually a really uncomplicated area: we’ve failed to adequately manage the risks around biased dissemination and withheld clinical trial results, and we should manage those.”

At the heart of it all, Goldacre maintains, is a self-evident truth: “You’ve just got to publish all the results of all of your trials. You wouldn’t choose a car based on only the positive results in a world where industry was allowed to delete half the reviews. It’s a very strange situation that we’ve allowed to emerge.”

The pharmaceutical industry’s reputation in the last twelve months has declined worldwide, a new survey has found.

Only a third of patient groups now believe that pharma has an ‘excellent’ or ‘good’ reputation, figures from PatientView’s independent 2012 annual review show. In 2011, 42% of respondents had the same opinion.

A global survey of some 600 international, national and regional patient groups showed that 66% of respondents felt the industry needed to do more to improve its corporate image and its relationship with patients.

Respondents were quizzed on their impression of 29 of the largest global pharmaceutical companies, including Pfizer, AstraZeneca, Boehringer Ingelheim and Roche.

Up to half of responses claimed that pharma had a ‘poor’ record in 2012 for its pricing policies. Nearly the same amount (48%) also claimed that the industry had a ‘poor’ record for being transparent over the last twelve months.

There was also a marked change in opinions of the way pharma manages adverse news about its products – down 29% compared to the 2011 results; of whether it has ethical marketing practices – a fall of 23% on the 2011 data; and of its relationship with the media – down 19% on last year’s results.

But the survey was not all bad news for pharma. As part of the study, respondents were asked to provide feedback on six key indicators that influence corporate reputation: patient-centeredness; patient information; patient safety; useful products; transparency; and integrity. Lundbeck topped the charts after it received the highest ranking overall and moved up three places on 2011’s chart – see below.

Gilead Sciences, which jumped from 10^th in 2011 to 2^nd last year, and Eli Lilly, which improved from 18^th to 9^th place, also had reason to celebrate.

The major private companies that provide NHS services are financially unstable and liable to pull out of their contracts.

A study by The Guardian found that of the six major private health providers involved in the carve-up of the NHS, three are already in crisis and none has a reliable financial basis.

Ramsay Health Care, Virgin Care, Harmoni, The Practice, Circle and Care UK all depend on parent companies or private equity investors, which have no obligation to maintain any loss-making enterprise.

Lack of profit from some NHS service contracts has already taken The Practice, Harmoni and Circle into financial crisis as service providers.

The Guardian analysis summed up the problem: “those who provide the care for patients are not the ones who decide whether that care can continue to be provided.”

Ramsay Health Care and Virgin Care depend on the investment of parent corporations that have widely varied interests, and the other four leading independent providers of NHS care are dependent on private equity investors.

In both cases, this is not a relationship traditionally associated with long-term consistency of service provision where profit margins are low.

The analysts predict that as the NHS struggles to cut costs, these providers will be caught between a demand for increasing profit and a demand from the NHS for lower operating costs.

Harmoni has already withdrawn from health provision, selling to Care UK in December 2012.

Circle, the first private health provider to take over an NHS hospital, has seen Hinchingbrooke Hospital in Huntingdon lose £4m in six months – double the rate it had forecast. The company’s high-profile Chief Executive, Ali Parsa, has resigned.

The Practice has withdrawn from many service contracts it took over from United Health. In early 2012, GP practices run by The Practice in north London, Nottingham, Leicester and Woking were shut down, without consultation, because they were loss-making.

The analysts conclude that transparency and continuity of service provision are liable to be compromised by such arrangements.

New NICE guidance for local formularies requires them to include NICE-approved medicines within 90 days, and not to repeat or challenge NICE appraisals.

CCGs are also required to publish all local formulary information online in a way that is accessible and clear to patients and the public.

This guidance reflects the Government’s commitment to ending the ‘postcode lottery’ and ensuring that local prescribing makes innovative drugs available.

All CCGs are required to publish formularies by 1 April 2013, and the new NICE guidance aims to help them combine three priorities: meeting local needs, reducing variation in prescribing, and enabling rapid uptake of innovative therapies.

Until now there have been no standard guidelines for putting together a local formulary, and this has allowed wide variation in prescribing between locations.

According to the NICE good practice guide, local formularies must follow three rules to ensure they are fit for purpose and compliant with law:

• Medicines with a positive NICE appraisal must be included (where clinically appropriate and relevant to the services provided) within 90 days.

• There must be no local duplication of, or challenge to, a NICE appraisal.

• All relevant local formulary information must be published online in a clear and simple way accessible to patients, the public and stakeholders.

According to Professor Alan Silman, Chair of the Guidance Development Group, the new guidance “allows formularies to continue to respond to local needs and circumstances but also ensures that NICE’s decisions to approve an intervention and other appropriate inputs into formulary production are taken up in a timely and transparent manner.”

ABPI Chief Executive Stephen Whitehead said the guidance was “an important step forward”. However, he added, there needs to be “strong local implementation of this guidance” before the formularies are published.