A plea to pharma to campaign for transparency: interview with Ben Goldacre

Rebecca Aris interviews Dr Ben Goldacre

British physician, academic and science writer

pharmaphorum speaks with author of ‘Bad Science’ and ‘Bad Pharma’, Dr Ben Goldacre, on his views on publication bias in the pharmaceutical industry and what can be done to begin to resolve the problem.

Dr Ben Goldacre is a best-selling author, broadcaster, medical doctor and academic who specialises in highlighting scientific inaccuracy. Driven by his annoyance at inaccurate science reporting, Ben is determined to highlight problems in this area. His view is ‘unpicking bad science is the best way to explain good science’ and that by drawing more attention to problems they can begin to be fixed.

His first book, Bad Science, sold half a million copies and his blog receives 100,000–200,000 unique visitors a week, and has been running for over ten years. Ben released a book earlier this year called ‘Bad Pharma: How drug companies mislead doctors and harm patients’.

He speaks with pharmaphorum on the problem of publication bias in the pharmaceutical industry and how he thinks we can begin to find a solution. He openly invites individuals from the industry to get in touch with him to join forces in addressing this problem.

To listen to the full interview, please click on the play button below, with a shortened transcript further below.

&nbsp,

&nbsp,

Quicklinks

Dr Ben Goldacre shares his views on publication bias in the pharmaceutical industry and how this problem needs to be addressed.

00:15 – Ben’s background and what got him interested in journalism.

01:26 – The focus of Ben’s writing.

02:34 – Ben’s views of science reporting in the British media.

05:51 – What Ben thinks pharma is doing wrong with regards to publication bias and the lack of transparency.

13:54 – What organisations Ben thinks are making a positive change in this area.

18:13 – What pharma can do to address publication bias.

22:24 – Ben’s view on how pharma interacts with physicians.

Interview summary

RA: How do you think we can encourage more accurate reporting of science in the British media?

BG: Drawing attention to problems is an important first step to fixing them. The public consists of a lot of very smart clued up people, and often they can be very helpful in coming up with good solutions in how to fix these problems.

There’s also been a fantastic upsurge in bloggers providing really valuable alternatives to dodgy coverage in the media, and getting very high traffic.

The problem of dumbing down has been fixed now by mainstream media being bypassed, because there are so many other great sources of information online.

Universities are now producing great content and putting it online. One example is a fantastic piece from UCL Social Science Research Unit on a pop science short book that they had made for the general public.

So although there are problems with science and health journalism sometimes being sensationalist or inaccurate, I feel very, very optimistic about the issue of news being dumbed down, because there are so many great people producing alternative sources online.

&nbsp,

“…it’s possible for very good people with strong principles to participate in wider system failures…”

&nbsp,

RA: You talk passionately about publication bias and the lack of transparency within pharma, what do you think pharma is doing wrong?

BG: There are a lot of issues in the pharmaceutical industry that I think are problematic. They’re ongoing and they’ve been around for a long time without being properly addressed. But that’s not to say that there aren’t a huge number of very, very good, very ethical professional people working in industry.

I think it’s possible for very good people with strong principles to participate in wider system failures that result in people being harmed in quite large numbers without themselves necessarily being bad people as individuals.

Beyond doubt the most important issue facing us today is the lack of transparency. The reality is people are allowed to withhold unflattering information about their clinical trials. They always have been and they still are today. Our best estimate – looking just at publication bias in terms of trials that don’t get published in academic journals – is that about half of all of the studies that are conducted and completed never get published.

&nbsp,

“Beyond doubt the most important issue facing us today is the lack of transparency…”

&nbsp,

That’s why we often need to have access to the full statistical analysis plan. We need the protocol to be registered before the trial begins so that people can see whether the primary outcomes have remained the same throughout the trial.

Lastly, we need access to the results of the study. Laws that have been passed to try and address this have failed. For example, the FDA amendment back in 2007 was supposed to mean that all trials conducted with at least one site in the US and should post their results in basic summary table format to the website clinicaltrials.gov.

When that law was passed everybody thought that the problem of trial results being inaccessible had been fixed forever. But unfortunately that’s turned out to not be the case.

An audit was conducted and recently published by Prayle et al1. As a result, we know that only one in five of the trials that were supposed to meet that reporting requirement actually complied and reported their results to clinicaltrials.gov within a year. Despite that fact, no fine has ever been levied.

Publication bias is an ongoing problem. It’s not just about trials being withheld from doctors and patients in terms of whole study reports. The Cochrane collaboration has had information about the conduct of Tamiflu trials withheld from them by Roche for several years2. That’s just one illustration of how serious this problem is.

The reality is if we can’t get access to vitally important information about the conduct and design of the study from the clinical study report, we don’t know what the results mean or if we can trust the results.

We need very simple clear legislation that says that all information about all clinical trials on all drugs currently in use must be made available to doctors and patients.

The industry really should be campaigning for everybody to work competitively to high ethical standards.

I think it’s really fantastic that Andrew Witty at GSK said, “We’re going to be more transparent about our clinical trial data”. However, we will have to wait maybe two years to see what the results of these promises are. But it’s fantastic and I’ve got huge respect for Andrew Witty.

But we don’t solve these problems by individual people being good and nice, we solve these problems by getting regulatory change across the board in industry so that companies aren’t obliged to compete on territory where it’s in their interests to behave less ethically.

Andrew Witty and anybody else working in the pharmaceutical industry should come together and themselves actively campaign for greater transparency. It would be really important and powerful if industry could just be a little bit more transparent, but more than that start campaigning themselves for more transparency.

&nbsp,

“Andrew Witty and anybody else working in the pharmaceutical industry should come together and themselves actively campaign for greater transparency.”

&nbsp,

RA: What organisations do you see to be making a more positive change in this area?

BG: I was very heartened with the campaign that has arisen just over the last few weeks. I organised a letter to the Times, drawing attention to the problem of publication bias and asking for the government to take this problem more seriously. It was co-signed by lots of senior people from academia and medicine. There was also a very supportive editorial in the British Medical Journal, written by Fiona Godlee, the editor in chief3. So there’s a lot of very positive support from journals and doctors.

It’s really important that Royal Colleges, the faculties, and the societies all stand up and make a clear positive statement that selective non-publication of unflattering information about clinical trials is research misconduct, because it’s a very important ethical issue.

I’m also really pleased to see that the government has started to engage very constructively with this.

There are many of us in academia and in science who are very keen to help government understand the extent of this problem, and work on addressing it. So there’s a lot of really great positive forward movement here from people who are able to look at these problems and think of ways to fix it. And, as I said, it’s really important to involve the public in this discussion.

RA: What would you like to see pharma doing to address these issues and manage publication bias?

BG: The first and most important thing is to make a clear public statement that you recognise that this is a problem. The ABPI have issued flat outright blanket denial, they have said that all of the issues in the book are historical, and that all of these problems have been fixed 4. That’s really very simply not true!

So it’s really important that people from industry stand up and make a clear statement that these are ongoing problems, and engage constructively with people like me, politicians, academic, and journal editors, who are working towards trying to fix this problem and draw more public attention to it so that we can get popular purchase on it.

The time has come for people like the ABPI to engage constructively with what are very reasonable concerns. I don’t think it’s reasonable in 2012 to say we’re not going to talk with people who are raising concerns about publication bias.

I would encourage individuals and industries, firstly to get in touch if they would like to be involved in forming broader coalitions about addressing this problem. My email address is ben@badscience.net and we’re currently building a website at www.alltrials.net which will have further resources and I hope that people from industry, either in an individual capacity, or in a broader capacity will be able to sign up to that. So I would encourage people to get involved and to support those initiatives, and I would be very pleased to hear from anybody who has got anything constructive to add on this.

&nbsp,

“If you put me in charge of MRC funding for the next year, I would cancel all primary trials research, just for one year…”

&nbsp,

RA: Now shifting the focus back to you as a doctor, pharma interacts with doctors and received criticism in this area, looking at just that area how should pharma be better interacting with physicians?

BG: This is actually something that I think is much less important than the problem of transparency in medicine, and I don’t particularly think that pharma are the bad guys here. I think this is a system failure.

If you put me in charge of MRC funding for the next year, I would cancel all primary trials research, just for one year, and I would spend all the money that we have on better ways of synthesising, summarising evidence, and then better ways of disseminating it to practitioners, decision makers, nurses and nurse practitioners, prescribing nurses, but also physiotherapists, occupational therapists and commissioners of health services.

We’ve been actually quite good in medicine in comparison with education or politics at developing an evidence base for the decisions that we make, but we’ve been very bad at synthesising individual pieces of information together, disseminating them to practitioners, and auditing how those decisions are put into practice. I think that should be a much higher priority for the Department of Health. There are huge savings to be made in getting people to implement the evidence we already have as efficiently as possible, to make cost-effective decisions and making sure that you’re using the cheapest statin if there’s no evidence that more expensive statins are better. That frees up money to spend on truly innovative new products from the pharmaceutical industry, because of course people do make good drugs, and people should be able to make money out of good drugs.

One of the problems for innovation in the sector is that you can also make money out of drugs that aren’t very good, and I don’t think that should be a right for the industry.

The medical world is a very interesting and peculiar corner of public procurement, because it’s an area where huge amounts of money are being spent, but by individuals, doctors, spread all across the country, and each in their own small atomic corner of the NHS. Now we should view this as a question of how we optimise procurement by making sure that prescribing and treatment decisions by doctors are as rational and evidenced based as possible.

The cost of creating evidence and disseminating evidence to reduce irrational prescribing, inefficient prescribing, is almost certainly less than the cost of the inefficient prescribing itself, and so there’s a clear win here for everybody.

Industry is not helped by being able to make profits from drugs which are more expensive than their generic competitors but no more effective, because those kind of misaligned incentives send a very poor signal for innovation. If you want to get people to innovate you have to reward excellence in the pharmaceutical industry, and not reward mediocre drugs.

RA: Doctor Goldacre thank you very much for your time and for your insights.

BG: Thank you very much.

References:

1. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012,344:d7373.

2. http://www.bmj.com/tamiflu

3. Godlee F. Clinical trial data for all drugs in current use. BMJ 2012,345:e7304.

4. Ben Goldacre v the Association of the British Pharmaceutical Industry http://www.newstatesman.com/sci-tech/sci-tech/2012/10/dr-ben-goldacre-vs-association-british-pharmaceutical-industry (accessed 21st November 2012).

Subscribe to pharmaphorum on YouTube to be the first to hear about new videos – http://www.youtube.com/pharmaphorum.

pharma-PPM-toolbox-5-6-March-2013

About the interviewee:

Ben Goldacre is a best-selling author, broadcaster, medical doctor and academic who specialises in unpicking dodgy scientific claims from drug companies, newspapers, government reports, PR people and quacks. Unpicking bad science is the best way to explain good science.

Ben has written two books.“Bad Science” (4th Estate) has sold over 400,000 copies, is published in 18 countries, and reached #1 in the UK paperback non-fiction charts. His book exposing bad behaviour in the pharmaceutical industry, “Bad Pharma” was published earlier this year 4th Estate.

Ben has written the weekly Bad Science column in the Guardian since 2003.

There are lots of clips of Ben on telly here, and a talk at TEDGlobal here. He has made various documentaries for BBC Radio 4 and The World Service on science, libel, policy, and epidemiology: The Placebo Effect is a two-part series, The Rise of the Lifestyle Nutritionists is another. He’s appeared on the Today programme lots of times, QI, Any Questions, Newsnight, Start The Week, The Now Show, Loose Ends, PM, Quote Unquote, Watchdog, and various other things.

You can contact him on ben@badscience.net, he can’t reply to everything, but it does get read.

What should pharma be doing to address publication bias?