INTERVIEW

bmj.com/podcasts Listen to a podcast interview with Andrew Witty at bmj.com/multimedia ANDREW WITTY The acceptable face of big pharma? Following GlaxoSmithKline’s announcement that it will open up its research data, Rebecca Coombes spoke to CEO Andrew Witty about his attempts to change the company GEOFFPUGH/THE TELEGRAPH DAILY

rug company bosses have a tough time GSK badly needs this shot of good publicity: look in the mirror around, ‘What do I want to do getting positive headlines. As reputa- last year it was fined $3bn (£2bn; €2.3bn) in the with this job?’ And the answer in my mind was tions go, they usually have to be con- United States for selling the antidepressant drug to change the way we operate—and try as a con- tent to rub shoulders with bankers and paroxetine (Paxil) for unapproved use in children, sequence to change the industry, although I can’t oil executives. So it was surprising that concealing safety evidence from the Food and control that.” Da member of this tribe was recently singled out Drink Administration (FDA) on its leading diabe- Witty wants to reform GSK in three areas; data for praise by one of the industry’s harshest critics. tes product, and offering doctors lavish incentives transparency, access to medicines, and intellec- In a spectacular public relations coup last to promote its medicines.2 More of this later, but tual property. On the last two, he can point to month, Andrew Witty, chief executive officer the fine stands as the largest in US history for a inroads in developing countries—for example, of Britain’s biggest drug company, GlaxoSmith- drug company. changing the drug pricing structure that blighted Kline, announced the company was to make huge GSK’s anti-AIDS treatment in Africa. The com- swathes of its research data public.1 By signing Fresh approach pany is trialling the first child malaria vaccine, GSK up to AllTrials, the campaign that urges drug At 48, Witty is on the young side to lead a multi- one that when approved Witty decrees will not companies to disclose detailed clinical study national company, one with nearly 100 000 be sold for profit. “In some situations we develop reports as well as the results of all drug trials— employees in more than 100 countries. He’s medicines and we need to get a strong economic not just the ones with favourable results—Witty part of a new breed of company bosses, comfort- return, and in others we develop a vaccine like seemed to be ushering in a glorious new era of able talking about his ideals, his love of Asia and malaria where we’re not looking for an economic openness. Africa, and the need for corporate openness. He’s return and it’s part of our global contribution.” Ben Goldacre, doctor, AllTrials campaign even, whisper it, said the word “sorry” for some Witty also set up a patent pool for neglected dis- leader, and author of Bad Pharma, which fiercely of his company’s past misdemeanours. Could eases to stimulate drug development in this field. critiques the industry, called it “a cartwheel Witty be the acceptable face of “big pharma”? moment.” An economics graduate from Nottingham Transparency Back in October, Witty had also committed GSK University, Witty has spent his entire career at The costs of these initiatives won’t trouble GSK’s to make anonymised patient level data from clini- GSK. He shrugs off the charge that he’s a chief balance sheet. The business is in pretty good cal trials available to researchers. executive bred in captivity, lacking the long range shape under Witty—in 2012, GSK reported pre- perspective to reform such a mammoth organi- tax profits of £6.7bn. However, Witty’s drive sation. On the contrary, says Witty, his strength towards transparency is not without risk. If GSK SOME WITTY FACTS comes from spending most of his career at arm’s is truly opening up the data vaults—and the proof • Witty is 48 years old length from GSK’s polished glass headquarters is still very much in the pudding—this means • He joined Glaxo UK in 1985 in London. the release of potentially unflattering trial data as a management trainee, “I’m what business school would call an ‘out- to doctors and patients that could threaten the straight from Nottingham sider insider.’” By this he means he’s always been reputation of its highly profitable blockbuster University, where he read economics on the edges of GSK’s empire. “I was never really drugs. Will shareholders tolerate the CEO shar- in the centre. I spent a lot of my career in Africa, ing research data on a drug in the middle of a 10 • In 2011, Witty’s base salary was £1m (€1.2m; $1.5m) and his bonus was £2m in Asia, and that more than anything really influ- year cycle of sales? enced the way I think about the world. Of course, the jury is still out on whether GSK • Since Witty became CEO in 2008, GSK’s share “When you’re in charge of an organisation, will make good on this new transparency pledge. price has increased by 25% you’re not just in charge of delivering the next bit When the BMJ met Witty last month, the com- • In 2012, GSK’s pre-tax profits were £6.7bn of output or the next quarter. You’re in charge of pany was about to undergo its first real test of this • Witty was knighted in the 2012 New Year trying to set its culture and the philosophy. When commitment. Buoyed by GSK’s announcements, honours list I was told I had the job, I took a very deliberate independent researchers from the Cochrane

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Witty has spent his entire 28 year career at the some retired staff equipped with a long corporate ether that others are moving in this direction. But company, mostly in Africa (right) and Asia and memory, to deal with requests going back to the of course there is a spectrum of view; there are not at the London headquarters (above) company’s formation in 2000. some people who are probably closer to our posi- “Our intent is to be comprehensive and not tion and some maybe less close.” Collaboration reignited a three year long cam- partial, right? We are going to try and have paign to extract research data on the company’s as much [as possible] out there in the public Past problems leading influenza drug zanamivir (Relenza). domain. And absolutely judge us, but we are Whether data transparency is a matter of honour A full analysis of trial reports would allow going to do it. for Witty, or a canny way to reverse GSK’s reputa- Cochrane’s independent academics to answer “We are going to create a dedicated organisa- tional misfortunes, we can’t tell. The company’s questions about the benefits of zanamivir. A tion with the sole job of going back and finding reputation certainly hit the doldrums in July similar review of Roche’s oseltamivir (Tamiflu) all these documents, putting them together so 2012, with its record $3bn US fine for market- is planned for this year. There are longstanding that you can go to one trial and say, here’s every- ing breaches, including withholding safety data concerns that these drugs have thing you need. The priority will on rosiglitazone (Avandia), the company’s best been overhyped. True to its word, I want to change the be the most heavily prescribed selling diabetes drug. These shocking transgres- GSK has now sent Cochrane way we operate—and drugs first, so we can get the sions were in Witty’s in-tray when he took over clinical study reports—some try as a consequence to data out there for the things that as chief executive officer in 2008—Frenchman 15 000 pages of data—on zan- change the industry are affecting the most people.” Jean-Pierre Garnier had led the company during amivir. However, the team was Witty says he’s not afraid of the period covered by the fine. The final settle- dismayed to find the data heavily redacted in new adverse effects in any of these drugs com- ment last year was, says Witty, “the full stop mark parts—including the removal of all patient identi- ing to light as the result of independent scrutiny on an end of a lot of historic activity.” fier numbers—and is assessing if these omissions of trial data. “We were determined to make sure it never make the data impossible to interpret. “My absolute view is if we’ve missed some- happens again.” These humble words are tem- Nevertheless, Witty is adamant he wants to thing in our analysis it’s got to be better for pered with a touch of bullishness: he wants to be change the way GSK operates and that transpar- every­body for it to be spotted. I don’t believe for a “precise” about where GSK erred over Avandia. It ency is a key element of this reform. This month second there is any malintent in any part of GSK. wasn’t that GSK deliberately withheld safety data the company opens a web portal through which But I can’t rule out that we sometimes get things from the Food and Drug Administration in the researchers can access the research data once wrong, make mistakes, or just look at the data in US, he says, but that some data were not submit- they’re given the green light from a GSK panel, a different way to other people,” he says. ted in the regular reporting systems. “It was an whose members are due to be announced. Of course, GSK may be just the first company absolute error, and we should have been slapped “The panel will be arm’s length and will have to see the writing on the wall. Governments and for it and we were. But all the safety information people in there who are not GSK insiders,” says Europe are waking up to the costs of hidden data was submitted to the agency in other systems. I’m Witty, adding that all researchers with a legiti- and research misconduct: British MPs are plan- not proud of it, but it’s not the same as deliber- mate trial question and protocol, who also com- ning an inquiry into clinical trials, and data dis- ately not presenting data.” mit to publishing their results, will gain access closure and there are calls for the powerful Public He says GSK has since been audited by the FDA to the data they request. Yes, some patient iden- Accounts Committee to investigate the cost to the and “I think we’ve absolutely nailed that issue.” tifiable information will be redacted, he says, NHS of missing data relating to the £500m spent But aren’t companies like GSK willing to pay but nothing else. The same goes for clinical on oseltamivir. billions in penalties as long as their rule break- study reports, including the appendices, which Will GSK’s actions live up to the fanfare of ing generates enough profits? Rosiglitazone, for researchers say contain information that is vital its various recent announcements? And will its example, has generated at least $10bn worth of for a full analysis to be done. GSK plans to cre- actions put pressure on others to follow suit? “I sales and paroxetine, another drug named in the ate a specialist team of 15 scientists, including think they will,” says Witty. “We hear through the settlement, $11bn.

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GSK’s drug pipeline In a challenging corporate we didn’t think they would go into depression because environment, and with talk be any better than what’s out there are no new biological of the drug industry falling there. And will people pay for targets. It’s why we withdrew off a “patent cliff,” Witty it? Because at the end of all this from areas like overactive talks of tough research and we can only continue if we get bladder: big unmet need but no development choices the rewarded for the innovation.” new targets.” company has made. For Instead the focus is on He thinks the UK government example, it has pulled out of respiratory medicine, oncology, could do more to stimulate and research on depression and and vaccines. There are also support innovation and takes a several neurological disorders. interesting exceptions like swipe at NICE’s quality adjusted “It’s a tough needle to Parkinson’s and Alzheimer’s, life year (QALY) threshold. “It’s thread because scientifically, “because we believe there are inappropriately low. The QALY biologically, there aren’t great better targets, we have better is the same in absolute points targets; it’s a poorly understood theories, and we think we can as it was in 1999, when it was set of mechanisms [with] not make better progress.” first adopted. And there’s no brilliant non-human models GSK has around 150 drugs in question that if the QALY had to develop drugs. As a result the pipeline, says Witty, and the been inflated over the last 14 you end up with very expensive biggest barrier to development years as everything else has, development programmes is finding new biological targets. well, for sure more medicines which fail at the end—almost the “We have a very simple would be being made available worse situation. You end up with paradigm—we will focus where in Britain. I’m not saying there

drugs which might, might jump we think there is significant should be unfettered access— BETHANYCLARK/THE TELEGRAPH DAILY the regulatory hurdle but then unmet need, and where we that everybody should be given have a very high chance of being think there is significant every new drug. But I think We’ve terminated a number of rejected by NICE and others,” bedrock of biological targets there should be greater focus very, very good drugs because we he says. for us to develop molecules on adoption of innovation once didn’t think they would be any “We’ve terminated a number against. Super obvious, super it’s been deemed to be safe and better than what’s out there. of very, very good drugs because simple, but that’s why you don’t effective and all the rest of it.” And will people pay for it?

Witty displays a flash of anger: “I completely “Compliance and enforcement are really But, ultimately, “if someone has done some- disagree with this. I’ve seen absolutely no evi- important. In the last five years, we’ve increased thing deliberately, with intent, which is a break dence at any level that people make that kind by about fivefold the number of compliance of the rules, they ought to be subject to what- of calibration or that kind of trade-off. I can tell investigators in the company. We have 50 000 ever are the sanctions of their society; it differs you the money is the least important part of these people meeting with doctors and health profes- [according to] the jurisdiction you are in.” things. These sorts of challenges from regulators sionals every day. We’ve created compliance hot- So what does it take to be a 21st century CEO are the most traumatising thing you could imag- lines so if an employee says look, a doctor has in the pharmaceutical industry? “I don’t think ine for a company. They are deeply distressing for asked me this, I’m not sure I can answer, [they you want to be a CEO unless you have an agenda. me, for large numbers of people down through can ring for advice,] they have to be thoughtful I think having a point of view is much more the company. Although [corporate malfeasance about how they react because the answer might important today than it was in the old days. And cases] end up looking very big, they often have be off-label and they need to be very, very care- you’ve got to have the energy and resilience to be their origin in just one or two things that went ful. We’ve seen huge spike-ups in the number of able to stick at it. Of course we need to develop wrong, or one or two people who didn’t quite do people who ask for advice.” new medicines and technologies, and, of course, the right thing. It’s not about the big piece. The In the US, the company has dropped bonuses we need to get a decent return on them. That’s 100 000 people who work for GSK are just like for drug representatives based on their individual what shareholders need. But we need to be in you, right? I’m sure everybody who reads the sales; instead staff get incentives for the quality step with society— not against society. People BMJ has friends who work for drug companies. of service they provide—if they score higher in say to me, what did you shareholders say when They’re normal people. This is not a special sub- their scientific knowledge tests, for example, or you cut your prices in Africa by 75%. But the set of the population. Many of them are doctors.” if they receive positive doctor feedback from one shareholders understand it’s all part of the If rotten apples and not endemic corporate of GSK’s customer surveys. blend. Where I was helped enormously on this is malfeasance is to blame, how does Witty propose I ask Witty if CEOs shouldn’t carry the can I grew up inside GSK and I knew the vast major- to root out bad behaviour? “We discipline; we for corporate malfeasance? It’s the only time he ity of people agreed with me. I just knew it.” either reduce pay or we terminate employment falters. “Well I think ultimately that’s the ques- Rebecca Coombes is magazine editor, BMJ, London of people who break the rules. We’re very aggres- tion for regulators and governments to decide. I WC1H 9JR [email protected] sive, much more so than we were historically on also think there’s a balance to be struck around Competing interests: None declared. that kind of thing.” something that was done deliberately or was it Provenance and peer review: Commissioned; not externally Only last November was a GSK representative an honest error,” he says. peer reviewed. slapped on the wrist at the Prescription Medi- He’s against the “tokenism” of “we don’t really 1 Kmietowicz Z. GSK backs campaign for disclosure of trial data. BMJ 2013;346:f819. cines Code of Practice Authority for off-label care who was responsible, let’s just have a head 2 Jack A. Mea culpa: are multibillion dollar fines promotion of eltrombopag (Revolade). How can on a stake,” and, “the kind of liability through forcing drug companies to clean up their act? BMJ Witty be sure his representatives are engaged in proxy that you happen to be in the building 2012;345:e4865. honest selling? therefore everybody is in trouble.” Cite this as: BMJ 2013;346:f1458

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