by Ben Goldacre
One study, for example, looked at whether academic papers said radiotherapy was a good idea for patients who’d had a particular kind of tumour removed, but where the stage of the cancer was not known: twenty-one out of twenty-nine radio-therapists thought it should be given, compared with five out of thirty-four clinicians from other specialities.115 A similar bias has been shown for surgeons and coronary bypass operations, surgeons and surgery for a bleeding ulcer, and so on. There has been startlingly bad behaviour from advocates of breast cancer screening, who have overstated the benefits and underplayed the harms (such as the medical risks from unnecessary procedures in wrongly diagnosed women) simply because they were passionately wedded to the procedure.
Conspiracy theorists – who are naturally attracted to the problems in medicine – go further, and build vast castles in the clouds, with huge interlocking tales of conflicts of interest. For them, someone is biased for all time, on every topic, because she has a sister who works for the government; or because somewhere in the university where she works, a person she may never have met has a view on a topic that the industry might find favourable. The conspiracy theorists will then announce that these are secrets which have been deliberately withheld, when in reality nobody could possibly have anticipated such elaborate and tenuous fantasies.
So for the most part, if only because it’s practical, academics and doctors tend to concentrate on getting declarations of major financial interests, often just within the past three years, and to leave these more exotic and intangible elements alone. Some do go further. The BMJ staff often declare their membership of political parties and other organisations – which is great, but when you step away from money, you drift into territory that starts to feel like an intrusion into someone’s personal life; more than that, as things become more tangential, the decisions about what to declare become more arbitrary, and so perhaps even more misleading, in the selection of what is declared and what is not. As younger people worry less and less about their Facebook security settings, perhaps the future will bring radical transparency for everyone.
But we have other fish to fry. Do people take a declared conflict of interest into account when they read someone’s claims? The evidence suggests that they do. In a trial from 2002, three hundred readers were randomly selected from an academic journal’s database and divided into two groups.116 Both groups were sent a copy of a short report which described how the pain from herpes zoster, or shingles, could have a substantial impact on patients’ daily functioning; but each group got a slightly different version. The readers in group 1 saw a paper with different named authors from the actual ones, and with a declaration of competing interests, stating that they were employees of a fictitious company treating the condition, and potentially held stock options in it. Readers in group 2 were sent the same paper, but instead of the information about its authors’ employment and stock options, it had a statement that the authors had no competing interests. The people in each group were then asked to rate the study, on scales of one to five, for interest, importance, relevance, validity and believability. Fifty-nine per cent of the questionnaires came back (which is remarkably high), and the results were clear: people who were told the authors had competing interests thought the study was significantly less interesting, less important, less relevant, less valid and less believable.
So it is clear that people care about conflicts of interest. And for that reason, specific financial relationships with drug companies are usually declared on academic papers. This system seems to operate reasonably well, but even when conflicts are clearly declared, it may only be on the academic paper, and not in the subsequent work derived from it, such as guidelines or review papers. One study from 2011 took a representative sample of meta-analyses – systematic summaries of all the trials in a field – and looked to see if they described the conflicts of interest of the individual trials they summarised. Of twenty-nine meta-analyses reviewed, only two reported the funders of the trials they included.117 This is clear evidence that the problem is not paid forward, and that meta-analyses – widely-read and influential documents – simply gloss over this important issue.
We should be clear that declaring conflicts is not a final fix, and that like any intervention it can have side effects which should at least be considered alongside the headline benefit. For example, some have argued that forced disclosure of conflict of interest leads doctors to engage in ‘strategic exaggeration’,118 knowing that their utterances will be discounted if it is believed that they are acting as shills, and there is some evidence for this in the behavioural economics literature, although only from psychology experiments conducted under laboratory conditions.119 They may also be affected by a sense of ‘moral licensing’: once you’ve declared your interest, you feel free to let rip with biased advice, because you know the recipient has been warned. These are interesting ideas: overall, I would rather have disclosure.
But these are details. I have a strong suspicion that when you see the scale of this problem you might be slightly amazed. A recent survey in the US looked at senior doctors. Sixty per cent of department heads were receiving money from industry to act as consultants, speakers, members of advisory boards, directors and so on.120
ProPublica, the US non-profit investigative journalism foundation, has done an astonishing piece of work with its Dollars for Docs campaign, creating a huge, publicly accessible database of payments made to doctors.121 Individual drug companies have been forced to post this pooled information on their websites, mostly after losing various legal cases. ProPublica has now aggregated data on over $750 million in payments from AstraZeneca, Pfizer, GSK, Merck and many more. The latest slice of data includes details of dinners: so I can tell you that a Dr Emert in West Hollywood ate $3,065 worth of food paid for by Pfizer in 2010, to take just one random example.122 But while for me this is a curiosity, for patients and others in the US this database has produced a remarkable series of insights, showing the power of putting a lot of information together in one place, where it can be searched and indexed. An individual can look up their own doctor, and see how much they pocketed, to the horror and anger of medics across the country. And anyone can look up whole groups of doctors, to see what horrors lie beneath: overall, 17,700 doctors received money, and 384 got more than $100,000.
What’s more, universities around the country seemed to have little idea what was happening on their own premises, until the data was presented to them clearly. When the University of Colorado, Denver, saw that over a dozen of its senior academics were giving paid promotional talks for pharma, it launched a complete overhaul of its conflict-of-interest policies.123 The Vice Chancellor was unambiguous: ‘We’re going to just have to say we’re not going to be involved with these [CME] speakers’ bureaus, because they’re primarily marketing.’ In some places, university policy was being routinely ignored. Five faculty members at Stanford were shown to be taking money to give industry-sponsored lectures, and had disciplinary cases launched against them.124
The database also made it possible to see what kinds of characters were being paid by industry.125 By cross-checking the doctors who had taken the most money against records of disciplinary proceedings, in just the fifteen biggest states, ProPublica found 250 doctors with sanctions against them for issues such as inappropriate prescribing, having sex with patients, or providing poor care; twenty doctors with two or more malpractice judgements or settlements; FDA warnings for research misconduct; criminal convictions, and more. Three different drug companies paid one rheumatologist $224,163 over just eighteen months to deliver talks to other doctors, even though the FDA had earlier ordered him to stop ‘false or misleading’ promotion of a painkiller called Celebrex, saying he had minimised its risks and promoted it for unlicensed uses. Eli Lilly paid a pain doctor $84,450 over a year, although he was censured by his medical board for performing unnecessary and invasive nerve procedures and tests on his patients. Eli Lilly and AstraZeneca paid $110,928 to a doctor who a
dmitted unethical and unprofessional conduct over allegations of improper prescribing of addictive painkillers, receiving several years’ probation from his medical board. And so on. Most companies admitted that they never check for this kind of thing. It’s a pretty damning judgement on the doctors and companies operating in this dark corner of medicine.
Remarkably, this transparency seems to be changing behaviour, and there is already some evidence that industry payments to doctors have begun to fall since they have become more visible to patients and the public through ProPublica’s site.126 It’s disappointing, in some respects, to think that doctors’ behaviour should be affected simply by whether their patients can find out what they’re doing, but for many that seems to be the reality, and we should at least applaud their change of heart. So Veena Antony, a professor of medicine, received at least $88,000 from GSK during 2009 to give promotional talks.127 Now she says she has given them up, wary of what patients might think: ‘You don’t even want the appearance that [you] might be influenced by anything that a company gave.’
Her anxiety tells a wider story: many doctors are worried about how the public might react to this kind of information, especially in a health-care market like the US, where patients can exert a lot of choice. When you take a drug, you want to know that it’s the safest and most effective treatment, chosen for you on the basis of the best possible evidence. Informed consumers might avoid doctors who accept industry teaching and hospitality, because these have been shown – as you’ve now seen – to change the decisions that doctors make for their patients. In the US, a new law called the Sunshine Act will shortly come into force, and it will make lots more information available, so that patients can find out about their own doctor’s involvement with industry.
You could be forgiven for believing that we are about to enter the same era of radical transparency in the UK, with patients able to make informed choices about whether their own doctor is independent and trustworthy. From 2013, after all, a new UK ABPI code of practice says that all drug companies must publicly declare how much money they have paid to doctors for their services: this figure includes speakers’ fees, consultancies, advisory board memberships and sponsorship for attending meetings. It’s a move that has been greeted with huge fanfare, and claims that it heralds a new era in transparency.128 Celebratory headlines have exclaimed: ‘Drug Companies to Declare All Payments Made to Doctors from 2012’.
But even if we excuse the way the starting date for this new era has already slipped back in time, inexplicably, from 2012 to 2013 since it was first announced, the new code faces a much bigger problem. Because it is yet another fake fix, and although it’s the last we will see in this book, it follows the same familiar pattern of everything we’ve seen already, from the International Committee of Medical Journal Editors promising it would only publish pre-registered trials (they didn’t stick to it, though everybody acted as if the problem was fixed, p.51), through the FDA’s new rules demanding publication within a year (not enforced, though everybody acts as if the problem is fixed, pp.52–3), to the European Union’s bizarre clinical trials register (a transparency tool whose content has been kept secret for almost a decade, p.52), and so many more.
To understand why this code is so flawed, you have to dig deeper than the news coverage, because in reality the ABPI has defined ‘Declare All Payments Made to Doctors’ with such elaborate sophistry and wiliness that it’s genuinely difficult to explain its plan briefly, in plain English: the reality is too far from what any sensible person would expect. The code simply requires that companies declare the total amount they’ve paid to all doctors. Is that clear enough? No: it makes it sound as if drug companies will be saying how much they paid to each doctor, because that would be the obvious thing to do. But I said ‘all doctors’?
I’ll try again: each company must simply declare two numbers, on a single piece of paper, and that is all. One number is the total amount of money it has paid to all doctors in the UK over that year, all rolled up into one big figure, of however many tens of millions of pounds; the other number is how many separate payments have been made. Is that clear yet? It might be easier with an example. Imagine one drug company paid £10,000 to a Dr Shill, £20,000 to a Dr Stooge, and 998 other similar-sized payments to another 998 different doctors. All it will tell you at the end of the year is: ‘We paid out £12 million, split between 1,000 doctors’.
This is meaninglessly uninformative, and tells us nothing at all.
Could we build a database ourselves, from scratch? In reality, no, because we lack a culture of transparency and litigation around drug companies, so there is no legal framework for obtaining the kind of information that ProPublica has curated. It is possible to try to work out which academic doctors have taken money, very crudely, from the declarations that individual doctors and academics make at the end of each academic paper, but these are only made at all if they are relevant to the specific research area of that single study. As a result, sourcing information from here would produce an incomplete patchwork of declarations; and what’s more, these declarations rarely give any figures. Since some people simply work for every company, giving an impression of universal obligation without favouritism, this can be very misleading (but has the added advantage of making you look like a very popular expert).
Sourcing information from the declarations on academic papers would also tell you nothing about the huge number of doctors who do no academic work, but who see patients, and are senior key opinion leaders in their local or professional area, and who are being paid large sums by drug companies to teach other doctors; it would tell you nothing about clinicians who accept hospitality; and it would tell you nothing about whether your GP sees drug reps, or accepts money to attend conferences. Essentially, we know nothing about which doctors take what.
What we need, ideally, is a centrally held register of personal or financial interests in the pharmaceutical industry: it could be voluntary, or it could be compulsory, and people have recommended for years that one should be created, but it has never happened. You might note that the most senior figures in medical politics – the people with medals, on the Royal College committees – are the people who would have to drive this through, and they are often the very people receiving the greatest income from industry work.
Doctors reading this would do well to note a lesson that has been learnt in recent years by journalists over phone tapping, and by MPs over their expenses: just because you think something is normal – just because everyone you know is doing it – that doesn’t mean outsiders will agree, when they find out. In Germany, following an investigation by Stern magazine, the police searched four hundred drug reps’ flats and 2,000 medical premises, finding that doctors were routinely accepting money and gifts (as we know). In 2010 two German doctors were convicted and sentenced to a year in prison for accepting bribes to prescribe one company’s drugs, on the grounds that this defrauded the insurance company that was ultimately paying for the treatment.129 Sixty-six per cent of fraud cases in America involve the pharmaceutical industry, and concern either marketing or pricing issues.130 Pfizer has agreed to pay over $60 million to settle a foreign bribery case in the US courts, and several other drug companies are in the spotlight for similar charges. The things that doctors have always regarded as normal are gradually giving rise to serious prosecutions.
But, of course, it’s not just doctors and academics who can have conflicts of interest: and this is the final part of our long, sorry story.
Firstly, these issues extend beyond medicine. In October 2011 the Australian newspaper began a ‘Health of the Nation’ series, sponsored by the Australian Medicines Industry.131 Money is given to newspapers like this to buy goodwill, to build closer relations, and to make it harder for them to be awkward in the future. Since newspapers have no culture of declaring such donations, there’s no standard slot for doing so at the bottom of the article, as you’d find in an academic journal, so they often go unmentioned, muc
h like the free holidays for travel writers. On top of that, journalists are frequently paid by drug companies to attend academic medical conferences, with hotel and flights provided, and asked to attend promotional events while they’re there, in exchange. I have names that I will give you socially, but not in print (just know that I have a list).
But more than that, this problem extends to the heart of the most powerful institutions in medicine, which can often become dependent on industry for core support and funding. This is well illustrated by a small recent case from the PMCPA, where the hospital representative from Lilly became frustrated with a diabetes consultant, who kept prescribing another company’s drugs. ‘We are basically paying you to use Novo Nordisk’s insulin,’ he complained, before explaining that funding for an educational post in the doctor’s institution was soon to be ‘reviewed’ by the Lilly Grants and Awards Committee,132 and probably cut, since the managers had noted that the doctor was failing to prescribe their drug.
Such funded positions are extremely widespread. Of course they are: they are the bread and butter of medical academia, because the vast majority of trials research is funded by industry, and much of it is situated in universities. Do all of these posts come with menaces? Of course not. At the extremes there are terrifying scandals – famous cases of people such as David Healy, Nancy Oliveri and others – where doctors have been pushed out of a university job because of criticisms they made of companies. As a young doctor, at the early and unglamorous early phase of a clinical academic career, I should probably be more afraid than I am. But the fate of occasional individuals who speak out is only part of the problem. The real story here is hidden from view: the doctors and academics who read stories of overt bullying and decide never to pressure their head of department, never to disappoint a funder, never to raise a concern about the appropriateness of a particular engagement with industry, in their academic unit. In every case, you can be sure it was dressed up in the individual’s mind as a small concession, necessary to keep a broader project on track, for the good of the department, of the patients, of everyone.