Who decides what gets studied?

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Clearly this situation is unsatisfactory, so how has it come about?

One reason is that what gets studied by researchers is distorted by external factors. [22] The pharmaceutical industry, for example, does research for its primary need – to fulfil its overriding responsibility to shareholders to make a profit. Its responsibility to patients and clinicians comes second.

Businesses are driven by large markets – such as women wondering whether to use hormone replacement therapy, or people who are depressed, anxious, unhappy, or in pain. Yet only rarely in recent decades has this commercially targeted approach led to important new treatments, even for ‘mass market’ disorders.

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Rather, within groups of drugs, industry has usually produced many very similar compounds – so-called ‘me-too’ drugs. This is reminiscent of the days when the only bread available in supermarkets was endless variations on the white sliced loaf. Hardly surprising, then, that the pharmaceutical industry spends more on marketing than on research. But how does industry persuade prescribers to use these new products rather than existing, less expensive alternatives?

A common strategy is to commission numerous small research projects showing that the new drugs are better than giving nothing at all, while not doing any research to find out whether the new drugs are better than the existing ones. Regrettably, industry has little difficulty in finding doctors who are willing to enrol their patients in this fruitless enterprise. And the same doctors often end up prescribing the products studied in this way. [23] Moreover, drug licensing authorities often make the problem worse by insisting that new drugs should be compared with placebos, rather than with existing effective treatments.

Another strategy is ghostwriting. This is what happens when a professional writer writes text that is officially credited to someone else. Most people will have come across ‘celebrity autobiographies’ that have clearly been ‘ghosted’ in this way. However, ghostwritten material appears in academic publications too – and with potentially worrying consequences.

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Sometimes the pharmaceutical industry employs communication companies to prepare articles which, unsurprisingly, cast the industry’s product in a favourable light. Once the article is ready, an academic is signed up, for an ‘honorarium’, to ‘author’ it. Then the article is submitted for publication. Commentaries are especially popular for this purpose.

Industry also targets journal supplements – separately bound publications that, while carrying the name of the parent journal, are often sponsored by industry and tend not to be as rigorously peer-reviewed as the parent journal. [24]

Marketing messages created and promoted in ways such as these have led to the benefits of products being oversold and harms being downplayed.

Drug companies also place adverts in medical journals to promote their products. Typically these adverts include reference  to sources of evidence to back the claims being made. These may be convincing at first glance, but a different picture emerges when the evidence is scrutinized independently.

Even when the evidence comes from randomized trials – which those reading the adverts might well assume to be a reliable assessment – all is not as it seems. When researchers analyzed adverts in leading medical journals to see whether the randomized trial evidence stacked up, they found that only 17% of the trials referenced were of good quality, supported the claim being made for the drug in question, and were not sponsored by the drug company itself. And it is known that research sponsored in this way is more likely to find a favourable outcome for the company’s product. [25, 26]

Commentaries in prestigious medical journals such as The Lancet [27] have drawn attention to the perverse incentives now driving some of those involved in clinical research, and the increasingly dubious relationships between universities and industry. A former editor of the New England Journal of Medicine asked bluntly ‘Is academic medicine for sale?’ [28]

Commercial priorities are not the only perverse influences on patterns of biomedical research which ignore the interests of patients. Many people within universities and research funding organizations believe that improvements in health are most likely to stem from attempts to unravel basic mechanisms of disease. So, they do research in laboratories and with animals.

Although such basic research is unquestionably needed, there is precious little evidence to support its substantially greater share of funding than research involving patients. [29, 30] Yet the consequence has been a massive outpouring of laboratory research that has not been properly evaluated to see how relevant it is to patients.

One reason for this distortion is the hype surrounding the hoped-for clinical advances that basic research, especially genetics, might offer.

Yet, as Sir David Weatherall, a distinguished clinician and genetics researcher, observed in 2011, ‘Many of our major killers reflect the action of a large number of genes with small effects, combined with a major input from the physical and social environment. This work is producing valuable information about some disease processes, but it also emphasises the individuality and variability of the underlying mechanisms of diseases. Clearly, the era of personalised medicine based on our genetic makeup is a long way in the future.’ [31]

Now, over fifty years after the structure of DNA was discovered, the cacophony of claims about early healthcare benefits of the ‘genetic revolution’ seems to be diminishing. Reality is starting to set in.

One scientist, talking about the potential for genetics to result in development of new drugs, commented ‘We have moved into an era of realism. . . . genetic aspects have to be looked at in association with other factors including environment and the clinical use of drugs. Just because a drug doesn’t work in a patient doesn’t indicate genetic variation in response is the cause.’ [32]

And an editorial in the science journal Nature, in an issue celebrating the tenth anniversary of the sequencing of the human genome, noted ‘. . . there has been some progress, in the form of drugs targeted against specific genetic defects identified in a few types of cancer, for example, and in some rare inherited disorders. But the complexity of post-genome biology has dashed early hopes that this trickle of therapies would become a flood.’ [33]

There is simply no way of bypassing responsibly the need for well-designed research in patients to test the therapeutic theories derived from basic research. And, all too often, such theories are never followed through to see if they do have any relevance for patients.

More than two decades after researchers identified the genetic defect leading to cystic fibrosis, people with the condition  are still asking a fundamental question. When will they see dividends to their health resulting from the discovery?

Even when research may seem relevant to patients, researchers often appear to overlook patients’ concerns when they design their studies. In a telling illustration, lung cancer doctors were asked to put themselves in the position of patients and to consider whether they would consent to participate in each of six lung cancer trials for which they might, as patients, be eligible. Between 36 and 89 per cent of them said that they would not participate. [34]

Similarly, in clinical trials in psoriasis – a chronic and disabling skin condition that affects about 125 million people worldwide – patients’ interests have been poorly represented. [35, 36] For example, the Psoriasis Association in the UK found that researchers persisted in using a largely discredited scoring system in many studies to assess the effects of various treatments. Among its deficiencies, the scoring system concentrates on measures such as total area of skin affected and thickness of the lesions, whereas patients, not surprisingly, are more troubled by lesions on the face, palms and soles, and genitals. [37]

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