Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (37 page)

But the greatest risk is that we fail to notice that our models of personhood, and what is normal, are being quietly engineered by a $600 billion industry.

Patient groups

We now arrive at the final murky and disappointing corner in our whistlestop tour of direct-to-consumer marketing. Patient groups perform a vital and admirable role: they bring patients together, disseminate information and support, and can help to lobby on behalf of people with the condition they represent.

In some respects it’s no surprise that many patient groups are funded by the pharmaceutical industry – we’ll see how many, and how transparently, in a moment – because on some issues, the desires of these two sectors are neatly aligned. A patient group wants money and resources, to lobby and to support its members effectively, and can benefit from specialist knowledge and business knowhow. A drug company offers this, and then it has its own needs: it wants to disseminate friendly messages for its brand, in a regulatory environment that prevents direct advertising to patients. It also wants to be seen as generous and socially responsible, like any other company, and we should recognise that illness is an emotional experience as well as a physical one: friendly assistance when you are at your lowest ebb can buy a good deal of loyalty.

But some industry interests are not so perfectly aligned with those of patients, as we already know. A company might want to increase sales of a product through the conventional covert marketing we’ve seen, but also by expanding the diagnostic limits of the disease, to enlarge its market. It has a special interest in selling
new
drugs, even though, as we’ve seen, these are the very products for which we know the least about the risks and benefits to patients, and for which the cost is – perversely, given the lack of information – highest.

If you read the pharmaceutical industry’s own commercial literature, it’s easy to see how it views relationships with patient organisations. Here is a PR company’s health-care strategist writing in the magazine
Pharmaceutical Executive
. This isn’t a smoking gun, but rather, a banal corporate explanation of why drug companies give patient groups money:

    Years before a new drug is launched, pharma companies and advocacy teams should map out how strong ties can advance corporate goals and brand objectives. Product managers see advocacy groups as allies to help advance brand objectives, like increasing disease awareness, building demand for new treatments, and helping facilitate FDA clearance of their drug…But there are a few things to remember: Some advocacy groups, especially the more established ones, will not endorse one product over another. Companies need to determine boundaries early to avoid getting in trouble.
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And so on.

How prevalent is industry funding? The health campaigning organisation Health Action International (HAI) looked at the patient groups working with the EMA, the European drugs regulator.
³⁶
Two thirds of them received funding from the pharmaceutical industry, with the average donation rising from €185,500 in 2006 to €321,230 in 2008, which generally represented about half the running costs for each organisation. Most worryingly, it also found that many of them had failed to declare this income clearly. In 2005 the EMA introduced ‘transparency guidelines’, but even by March 2010 only three patient groups had reported income from as far back as 2006 online. Despite this failure, all the organisations were invited back by the EMA to participate in stakeholder meetings.
*

Is there any evidence that this funding changes behaviour? I think so, and I think you will agree, though researching this has not been a priority for funders, despite the influence of these groups on practice. As one example, we can look at the ongoing cat-and-mouse game between industry and regulators over whether companies should be allowed to advertise, or give information directly to patients. This is recognised by most companies as an effective way to increase use of their pills, so they are keen to see the laws liberalised. Can we see any trace of this agenda in the patient groups funded by pharma? Another report by HAI, from 2011, looks at patient groups lobbying the European Commission and their lobbying patterns.
³⁷
All those that did not receive any funding from a pharmaceutical company wanted to keep the current regulations, preventing companies from promoting their drugs to patients. Groups receiving money from drug companies were significantly more likely to think that the industry should have a larger role in providing information about drugs to patients.

This is a worrying finding in itself, but it also undermines the very purpose of having independent patient charities involved on ‘multi-stakeholder’ policy-making forums: these already contain industry voices, formally representing themselves; the patient groups are supposed to represent patients.

But this correlation between voting patterns and industry income may not be simple evidence of foul play. While there will obviously be episodes of bad behaviour – people altering their views simply to attract industry money – I think there’s something much more interesting happening here. Patient groups’ interests and industry interests can legitimately overlap, as we’ve seen. So there is no need for people to explicitly change their views for the overall voice of patient groups to be distorted: the industry can simply give funding, and therefore a more prominent platform, to people who spontaneously express the views that it prefers. In this way, everyone can feel OK about themselves, while still participating in a broader system that produces a biased and distorted picture of patient opinions. This helps to explain why patient charities receiving industry funding are so angry and baffled if you suggest that their output is biased; even though, overall, it’s clear that their sector’s output is biased.

But that moral sop doesn’t change the reality we see on a regular basis, some of which is frankly ugly. As an example, the
Independent
newspaper recently examined some major media outcries around patient groups attacking NICE, and married up the attacks with the funding.
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When NICE advised against expensive arthritis drugs, the Arthritis and Musculoskeletal Alliance (ArMA) organised a letter criticising it in
The Times
, signed by ten rheumatology professors. Half of the charity’s income is from drug companies, and it didn’t raise a single word to criticise its industry funders over the cost of these drugs, despite this being a major policy issue, and plainly relevant to NICE’s decision. The National Rheumatoid Arthritis Society (NRAS) launched an appeal against the same decision, standing alongside ArMA and three drug companies, calling it ‘another nail in the coffin’ for its patients. NRAS receives over £100,000 a year from the industry, and it didn’t criticise the industry over pricing policy either. The National Kidney Federation attacked NICE over its rejection of new, hugely expensive, marginally beneficial treatments.
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Its press release was vicious, describing the decision as ‘barbaric’, ‘damaging’ and ‘unacceptable’. Half of the National Kidney Federation’s annual £300,000 budget comes from the pharmaceutical industry. Nowhere does the press release criticise the company charging tens of thousands of pounds for each person receiving its drug.

The head of NICE, Professor Sir Michael Rawlins, points out that the cost of manufacturing these drugs is often a tenth of the price for which they are sold, that we pay high prices in part for marketing (some of which goes directly to the patient groups), and that when we spend money on one thing, we can’t spend it on something else.
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This last gritty reality, which would present itself in any medical system without infinite money, is not often welcomed by patients and the public. Repeatedly, we come back to the same circle: we pay high prices for drugs; a quarter of what we pay goes on marketing; our money is then spent on things like patient groups; who in turn insist that we should pay very high prices for these drugs, undermining the very groups, like NICE, that try to determine the best choices for patients overall.

What can you do?

1. Drug advertisements do not serve to inform the public, and should be banned. Their expansion into Europe should be resisted.
   
2. If drug companies really want to help inform patients about health, they could pay into a central, independent repository, which can give grants to people with a good track record of giving evidence-based information to the public.
   
3. Patients, journalists and the public should be wary of people selling new diseases if they are also selling the cure.
   
4. Any firm running a disease-awareness campaign should declare in its advertisements that it is doing so because it is developing or marketing a product to treat it.
   
5. All educational materials should bear the same declaration.
   

Adverts to doctors

Addressing doctors directly is the most tangible way that drug companies try to influence prescribing practice, and this usually happens through print adverts, in academic journals. As with most marketing activity in medicine, we can be fairly sure that if the companies spend money on it, they know it has some value. The published academic evidence supports that view, as far as it goes, but again, this has not been a funding priority.
⁴¹
So, drugs are used more after their advertising programmes start, and less when they stop. Doctors who recognise the advert for a drug are more likely to prescribe it. Econometric models – as far as any mortal can follow them through – suggest that marketing has more influence on drug-usage patterns than the publication of new evidence, and so on.
⁴²

As you might imagine, drug adverts are supposed to be regulated for things like truthfulness and accuracy, but there are good reasons to worry that this is not done well. In the UK, the Prescription Medicines Code of Practice Authority administers the Association of the British Pharmaceutical Industry’s code of self-regulation. To find out more about the general tone of adverts, a Health Select Committee looking at the influence of the pharmaceutical industry in 2005 got the Institute of Social Marketing to examine a sample, and it found that the goalposts were mobile. While ads for drugs are supposed to contain ‘objective and unambiguous’ information, in reality they associated them with attributes you’d associate with any other product: ‘energetic’, ‘passionate’, ‘desirable’, ‘sexy’, ‘romantic’, ‘intimate’ and ‘relaxed’. The PMCPA clarified that ‘emotional messages’ were OK, if the material was ‘factual [and] balanced’.

But this is a side issue: what we care about most is whether adverts make assertions that are factually correct, and supported by good-quality evidence. That’s a simple thing to assess: you just gather together the claims from a representative sample of adverts, then check them against the available evidence, and one good example of this kind of study was published in 2010.
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Some researchers from Holland went through all the biggest medical journals in the world – the
JAMA
, the
Lancet
, the
New England Journal of Medicine
, and so on – between 2003 and 2005. Every advert that appeared in that time was included, once each, if it made a claim about the effect of a drug. Then they checked the references for all the claims in the ads, found the trials they referred to, and passed them to an easily exploited workforce of assessors (250 medical students who’d just finished their evidence-based-medicine training).

Each student independently checked the methods of two trials, and the associated advert, using objective criteria, like a well-established scoring system for assessing the quality of trials. Medical students are cheap, but they might not be reliable raters, so each trial was scored by between two and six students, and if there was a discrepancy in scores, the trial was reviewed by a panel of four academics. The results were abysmal. Only half of the claims in the adverts were supported by the trials the adverts themselves referenced as evidence; only half of the trials got a score of ‘high-quality’; and less than half of the adverts – in the leading medical journals in the world – referenced a high-quality trial which supported their claim.

This is just one study, but it’s fully representative of what has been found before. Another study from the
Lancet
in 2003 looked at all the claims from cardiac medication adverts in six Spanish medical journals: of the 102 references the researchers could trace, 44 per cent simply didn’t support the promotional statement.
⁴⁴
Another from 2008 on psychiatric drug ads found similar results.
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The story is the same for rheumatology drugs.
⁴⁶
Am I cherry-picking? The best current systematic review is free to read, well worth the time, and found twenty-four similar studies.
⁴⁷
Overall, it found that only 67 per cent of the claims in adverts are supported by a systematic review, a meta-analysis or a randomised-control trial.

Despite this overwhelming evidence, the British Department of Health has rejected calls for drug companies to be forced to publish corrective statements when they’ve been found to have made incorrect claims in their adverts.
⁴⁸
So doctors will never know when they have been misled.

As far back as 1995, around half of all medical journal editors responding to a survey agreed that they should check the content of the ads they accepted for accuracy, and even submit them for peer review.
⁴⁹
In reality, this almost never happens.
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If the factual claims in these adverts aren’t reliably backed up by evidence, then you already know all you need to know about whether the regulations governing these claims work: around the world, they don’t.