Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (39 page)

The question of why these gifts work is an interesting one, since their value is often fairly modest, once we set extreme cases of overt bribery aside. Social scientists writing on the culture of drug reps suggest that by giving gifts, they become part of the social landscape; and also that doctors develop an unconscious sense of obligation, a debt to be repaid, especially when stronger relationships are built through social events.
⁶⁷
In some respects these are obvious observations that apply to sales techniques in many fields: how easy is it to boot someone out and disregard their opinion when you’ve laughed together drunkenly over dinner? But in any case, as with most anaesthetic drugs, we don’t know
how
they work, but we know that they
do
work.

Even where the gifts are regulated, there is still hospitality; and it’s clear that meals, travel and accommodation will continue to be available as before. A quick browse through the PMCPA website shows that the self-regulation guidelines on sensible limits are regularly broken. There’s the odd visit to a strip club, business-class flights around the world, golf hotels and so on.
⁶⁸
One recent case concerns an unwise conference feedback document from Cephalon, describing how the company paid for doctors to go to an educational medical conference in Lisbon. Alongside the £50-a-head meals and early-morning bar bills for spirits and cocktails are comments from doctors like: ‘dinner was fantastic’, ‘great night again’, ‘we then went to a few bars and to a club until 3 a.m.…good photos to prove it!!!’
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‘All the customers were really looked after and spoke positively about Effentora – let’s make sure they start Rxing [prescribing] now!’

The cases which reach the public domain are only the tip of the iceberg, since there is little or no investigative work, so their exposure relies on competitors discovering and reporting a transgression, or doctors who are personally engaged in unethical behaviour reporting themselves to the authorities, which doesn’t happen often. Trips like the one described in the previous paragraph are used to influence the prescribing behaviour of doctors seeing patients like you, and spending NHS money: some with the booze, and some without, but in any case, the evidence shows that they are effective at changing behaviour.

One classic study followed a group of doctors before and after an all-expenses-paid trip to a symposium in ‘a popular sunbelt vacation site’.
⁷⁰
Before they left, as you’d expect, the majority said they didn’t think this kind of thing would change their prescribing behaviour. After they got back, their prescription of the company’s products increased threefold. In fact, this behaviour has become so widespread that the Serious Fraud Office announced in 2011 that it would be using new powers from the Bribery Act 2010 specifically to investigate corporate entertainment for NHS doctors, nurses and managers which goes beyond ‘sensible proportionate promotional expenditure’. When it’s even imaginable that doctors, nurses and NHS managers should be specifically targeted for fraud and bribery investigations, over their hospitality and other contacts with drug reps, you know there’s a problem.

Finally, alongside the gifts, the travel and the hospitality, drug reps are the conduit through which other benefits flow. They are the eyes and ears of the company on the ground, gathering information about local ‘key opinion leaders’, senior or charismatic doctors who influence their colleagues. These people are identified for special attention, but also – if they already like your drug – they are taken up, given extra staff, and put to good use in ways that I shall shortly discuss.

There is one final twist of data in our story. People working in drug sales teams are frequently paid by results. How can they know what drugs a doctor is prescribing, when that information is only in patients’ and doctors’ records? In the US, data on individual patients’ prescriptions are sold freely, and have become one of the most lucrative health-information markets around. Although it might come as a surprise to patients, American pharmacies sell their prescribing records to companies like Verispan, Wolters-Kluwer (an academic publisher) and IMS Health:
⁷¹
that last company alone holds the data on two thirds of all prescriptions ever filed at community pharmacies.

Patient names are removed (though if you’re the only person in your town with multiple sclerosis, everyone can see what you’re taking), but more importantly for drug reps, the doctors involved are identifiable. Using this information, a company can see exactly what drugs people are prescribing, hone its sales pitch, and get proof of whether doctors have kept the promises that they made to drug reps.

These promises are very important in the world of drug reps: they will sit down, explain the benefits of their pill, and try to get the doctor to commit to a concrete plan, for example to start the next five patients he or she sees with diagnosis X on the new drug. With a little peer pressure and a persuasive argument, a commitment might be made, and this can then be monitored using IMS data. As a result, favours to a doctor can be adjusted, and tailored pressure can be planned before the next visit. For the easily persuaded, the rep might ask: ‘Why are you prescribing that cheaper drug, doctor, when ours has fewer side effects? Look at this graph, comparing the two, which proves it.’ For the ‘spreader’, in drug rep parlance, the rep might ask: ‘Why are you prescribing such a random mix of antidepressants from the same drug class?’

Since the prescription data also includes doctors’ medical registration numbers, it can be married up with demographic and career information on them from other databases. So drug companies can browse through a region’s statistics, looking for young starters or influential seniors. One company called Medical Marketing Service will ‘enhance’ the prescriptions data with ‘behavioural and psychogeographic selections that help you better target your perfect prospects’.

Inevitably, this has become another area of cat and mouse. The American Medical Association has tried to implement a Physician Data Restriction Program, whereby individual doctors who dislike this kind of spying can opt out,
⁷²
and individual states occasionally try to restrict the sale of this data. But these restrictions result in lobbying, vast lawsuits, and the usual appeals. Vermont, for example, banned the sale of prescription data in 2007; the issue went to the Appeals Court, and then the US Supreme Court, whose judges finally overturned the decision, after great legal expense.
⁷³

What about the UK? The day may yet come when your prescription record is sold to any casual purchaser, but for the moment, drug reps have told me they rely on more human systems. Sometimes they ask the doctor if they can see their prescribing records – plenty say yes – but otherwise they go to the source: ‘The main way was going to the nearby chemists and asking them. Chemists will see you, and let you see the computer screen for a doctor’s prescriptions, so you’re able to see exactly how many prescriptions they’re writing.’ Which is nice. ‘And patient names, of course.’

What can you do?

1.
Don’t see drug reps!
If you’re a doctor, or a prescribing nurse, or a medical student, don’t see drug reps. The evidence shows that they will influence your practice, and that you are wrong to believe that they won’t.

2.
Ban drug reps from your clinic or hospital.
Drug reps increase costs and work against evidence-based medicine. All staff, whether medical or non-medical, can legitimately raise concerns about this in their workplace, and patient representatives can too. Hospital managers could consult on banning them (though many are on the gravy train too). Individual consultants may have more influence. In a smaller clinic setting, you could address the objections from colleagues, and explain why drug reps worry you. If reps can only be banned from some meetings, for local political reasons, then make good use of those meetings. You could make a poster display explaining why it is better not to have drug reps, and how commercial pressures distort evidence-based medicine. The six-foot-high pull-up displays that drug reps use to advertise their products and provide information are called ‘banner stands’: these can be ordered online, with whatever poster you choose to design, setting out the evidence on how drug reps harm medical practice, for as little as £50. If you make a good ‘no drug rep’ banner stand, send it to me, so I can share it.

3.
Encourage people to declare all gifts and hospitality to their patients.
If doctors, nurses and managers won’t stop accepting these benefits and visits, then ask them to publicly declare what they’ve taken, online and in waiting rooms, in a place that’s easily visible to patients and the public. Since they believe that these gifts and visits have no impact on their prescribing behaviour, they should be happy for the information to be shared with the NHS patients who pay their salaries.

4.
Ban drug reps from your medical school.
If you’re a medical student, and you believe, as I think I’ve shown, that drug reps are harmful, you could move to ban them from educational activities. If this proves difficult, you could audit industry promotional activity, and report back on it publicly, to shame your institution. This is important, as guidelines are often very different from reality. In one medical school where I have taught, drug reps have been banned from the hospital by the lead clinical pharmacologist, but the students say this is ignored by individual consultants. Collaborating between universities, you could also help produce data showing which medical schools are the worst for industry influence. Remember, the industry spends around a quarter of its revenue trying to influence doctors, and half of that on drug reps. This is a vast spend, amounting to billions of pounds, that you can influence.

5.
Report breaches of the drug rep behaviour code to the PMCPA
. By reporting what you see and hear, you can help to make self-regulation a little less farcical.

6.
Train medical students and doctors about the dangerous influence drug reps can have on medical practice.
To my mind, this is not a political act, but rather a legitimate part of training in evidence-based medicine. Doctors will be subjected to marketing activity throughout their whole working lives, for four decades of practising medicine after they leave medical school, and the majority report that they were not adequately trained to deal with this marketing activity.
⁷⁴
The references throughout this book will help you, and I’d be delighted if you were able to use this book as a starting point: if you produce good teaching materials, then do please share them.

7.
Regulations should change to prevent pharmacists sharing confidential doctor and patient information with drug reps.
This is obvious, and it should be policed. You could ask your local pharmacist and your doctor if they share your confidential prescription data with local drug reps, and if they do, ask them not to.

8.
Purge your drug-company junk.
If you work in medicine, and your office is filled with branded promotional material from drug companies, then gather up all those pens, mugs, calendars, memory sticks and trinkets, and put them in a bin. Or possibly a museum.

Ghostwriters

If I tell you that Katie Price did not necessarily write every word of her best-selling autobiography, then this is probably not a revelation to you. But then, nor is it a problem: you want something entertaining, and everyone knows that celebrities don’t write their own books. That is the culture and tradition of this kind of publication, and it’s an open secret.

From doctors and academics we have higher expectations. The reader of an academic journal reasonably assumes that what they are reading is an independent academic’s study, or review article, or opinion in an editorial. But this is quite wrong. In reality, academic articles are often covertly written by a commercial writer employed by a pharmaceutical company, with an academic’s name placed at the top to give it the imprimatur of independence and scientific rigour. Often these academics have had little or no involvement in collecting the data or drafting the paper.

What’s more, while the publication might look like a spontaneous project from an independent academic, it’s generally part of a carefully choreographed timetable of publications, all running to the marketing schedule for one company’s product. So, papers will appear before a new drug’s launch describing cross-sectional survey data which reveals that the prevalence of a medical condition is much higher than previously thought; others will review the field, and say that current treatments are widely regarded as ineffective and dangerous; and so on. By this mechanism, the entire academic literature, used by doctors to guide decisions – the only tool we have – is ghost managed, behind the scenes, to an undeclared agenda.

How common is this practice? As with most shady activity, it’s hard to gather clear data: the very point of ghostwriting is that it’s hidden from the audience, and academics and the industry are generally too ashamed to discuss it openly. But through a combination of leaked documentation, and cautious surveys promising anonymity, various estimates have been gathered.

One study from 2011 took a representative sample of all the papers in six leading medical journals – including the
Lancet
,
JAMA
, and so on – then contacted all 896 corresponding authors (the ‘lead’ author on the paper, whose contact details are always published).
⁷⁵
They included every kind of publication, from original research to review articles and editorial opinion pieces. Reviews and editorials are particularly important for the companies that employ ghostwriters, because they represent an opportunity to summarise the evidence for a whole field, in a readable format, and so set the frame for subsequent discussion and research. Knowing that the response rate was likely to be low, the researchers made a point of promising in their initial contact email that all responses would be treated with the utmost confidentiality. Remarkably they managed to get replies from over two thirds of the people they contacted. The information they received indicated that 8 per cent of all articles had ghost authorship: 12 per cent of research articles, 6 per cent of reviews, and 5 per cent of editorials.