Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (46 page)

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 admitted 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, much 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.

Beyond universities, there are other important institutions in medicine, such as membership organisations and the professional bodies, which all have their own engagements with industry. Here are some fairly random pickings from around the world. In America in 2009, the Heart Rhythm Society received $7 million, half of its revenue, from industry.
¹³³
The American Academy of Allergy, Asthma and Immunology took 40 per cent of its income from industry.
¹³⁴
The American Academy of Pediatrics officially supports breastfeeding, but receives about half a million dollars from Ross, manufacturers of Similac infant formula
¹³⁵
(Ross’s logo even appears on the cover of the AAP’s ‘New Mother’s Guide to Breast Feeding’). The
British Journal of Midwifery
runs adverts from powdered baby-milk manufacturers, and baby-milk companies run ‘training days’ for midwives in hospitals around the UK, which are well attended, because they are free. The American Academy of Nutrition and Dietetics is sponsored by Coca-Cola.
¹³⁶
In 2002 the American College of Cardiology thanked Pfizer for $750,000, Merck for $500,000, and so on.
¹³⁷

Payments to these groups will not be covered by the Sunshine Act in 2013, and for their equivalents in the UK, there is no law to help us see what lies on the balance sheets. It’s a very troubling state of affairs, and this is not simply an aesthetic concern: these organisations run conferences that are internationally attended, and set ethical norms for their members. More than that, they make the guideline documents which are followed around the world, and creating these often requires subjective judgement calls, especially where the evidence is thin. One study asked 192 authors on forty-four guidelines documents if they received money from industry, and on average four out of five said yes.
¹³⁸

This problem is vast and complex, and it won’t go away. We need to think very carefully about how to manage it.

What can be done?