Skip to main content

Bias and spin in reporting trials of new drugs for breast cancer

A paper published this week in the Annals of Oncology has demonstrated bias in the reporting of  outcome and toxicity of phase 3 randomized controlled trials (RTCs) for breast cancer. These trials are the final stage of testing of the efficacy and toxicity of a new drug or treatment before approval by regulatory agencies.

Papers published in scientific and medical journals have an abstract, a summary of the findings, and it is in this that the results are often presented in a biased way. Of the reports of 164 trials they reviewed, 33% of them showed bias in the reporting of the primary end point (PE) and as many as 67% in reporting the toxicity. Bias in reporting of outcome is common for studies with negative PEs.  Reporting of toxicity is poor, especially for the studies with positive PEs. It isn't that the authors don't give the correct result in the body of the report. The problem is that they put a 'spin' on them.    It is shocking but perhaps the finding is not surprising.

It is often argued that science is 'ethically neutral'. I have never subscribed to such a view. There isn't an ideal position of neutrality;somewhere from which we can see things free from assumptions or even prejudice. There is always a view from somewhere; a perspective that influences the way in which we see or interpret apparently objective data. In short there isn't a view from nowhere.

Science tests ideas, usually by first framing them into clearly testable hypotheses. What this tells us is that science is a human activity, it isn't a body of knowledge existing in some rarefied library. As soon as we touch it we frame it. We bring it into our world view.  It is also the case that science rarely if ever produces definitive answers. For all studies there are caveats; it might be difficult to control or account for all possible variables. This always provides leeway in interpretation of results and it is here that bias and spin are often in play.

Emphasising the positive over the negative in results is a judgement. In the case of Phase 3 human trials such judgement can have significantly harmful consequences. Ethical science isn't simply a matter of 'getting the right result' or the 'result right'. Ethical science should always be alert to its vulnerabilities. It has motive, it involves perspective and decision. Where there are choices there must always be ethical consideration. Scientists should consider the consequences of any bias they may introduce into their reports.

Comments

Popular posts from this blog

The lion and the wildebeest

Birds flock, fish school, bees swarm, but social being is more than simply sticking together.  Social groups enable specialisation and a sharing of abilities, and enhances ability, learning and creating new tricks. The more a group works together, the more effective they become as a team.  Chimpanzees learn from each other how to use stones to crack nuts, or sticks to get termites.  All around us we see cooperation and learning in nature.  Nature is inherently creative.  Pulling together becomes a rallying cry during a crisis.  We have heard it throughout the coronavirus pandemic.  "We are all in this together", a mantra that encourages people to adopt a common strategy. In an era of 'self-interest' and 'survival of the fittest,'  and 'selfish gene', we lose sight of the obvious conclusion from the evidence all around us.   Sticking together is more often the better approach.  This is valid for the lion as it is also for the wildebeest.   We don't

No evidence for vaccine link with autism

Public health bodies are worried that an alarming drop in childhood vaccinations is leading to a resurgence of diseases in childhood that we had all but eradicated.  Misinformation and scare stories about the harmful effects of vaccines abound on the internet and in social media.  Where they are based on 'science', it is highly selective, and often reliance is placed on falsehoods.  Conspiracy theories also abound - cover-ups, deception, lies. As a result, too many parents are shunning vaccinations for their children.  So, what does the published, peer-reviewed literature tell us about vaccincations? Are they safe and effective, or are there long term harmful effects?  A new report now provides some of the answers. New evidence published in the Cochrane Library today finds MMR, MMRV, and MMR+V vaccines are effective and that they are not associated with increased risk of autism. Measles, mumps, rubella, and varicella (also known as chickenpox) are infectious diseases cau

Therapeutic animal stress

Interacting with animals is known to be therapeutic,  particularly in reducing stress.  But do we consider sufficiently the effects this may have on the animals involved?   We might assume that because it is calming for us, then it must be so for the therapeutic animals, but is this so?  New research suggests that it isn't always without stress for the animals involved.  Positive human-animal interaction relates to changes in physiological variables both in humans and other animals, including a reduction of subjective psychological stress (fear, anxiety) and an increase of oxytocin levels in the brain.  It also reduces the 'stress' hormone, cortisol. Indeed, these biological responses have measurable clinical benefits.  Oxytocin has long been implicated in maternal bonding, sexual behaviour and social affiliation behaviours and in promoting a sense of well-being .  So far, so good.  We humans often turn to animals for stress relief, companionship, and even therapy.  We kno