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

Ian Duncan-Smith says he wants to make those on benefits 'better people'!

By any account, the government's austerity strategy is utilitarian. It justifies its approach by the presumed potential ends. It's objective is to cut the deficit, but it has also adopted another objective which is specifically targeted. It seeks to drive people off benefits and 'back to work'.  The two together are toxic to the poorest in society. Those least able to cope are the most affected by the cuts in benefits and the loss of services.

It is the coupling of these two strategic aims that make their policies ethically questionable. For, by combining the two, slashing the value of benefits to make budget savings while also changing the benefits system, the highest burden falls on a specific group, those dependent on benefits. For the greater good of the majority, a minority group, those on benefits, are being sacrificed; sacrificed on the altar of austerity. And they are being sacrificed in part so that others may be spared.

Utilitarian ethics considers the balan…

Keir Starmer has a lot to offer

The Labour Party is in the process of making a decision that will decide whether it can recover from the defeat in 2019 General Election.  All the candidates have much to offer and are making their case well.

No doubt for some the decision will be difficult.  Others may well have made up their minds on the simple binary of Left-wing-Right-wing.

The choice should be whoever is best placed to pull the party together.  Someone who can form a front bench of all talents and across the spectrum in the party.

That is what Harold Wilson did in the 1960s.  His government included Roy Jenkins on the right and Barbar Castle on the left; it included Crossman and Crossland, and Tony Benn with Jim Callaghan.  It presented a formidable team.

Keir Starmer brings to the top table a formidable career outside politics, having been a human rights lawyer and then Director of Public Prosecutions.   He is a man of integrity and commitment who believes in a fairer society where opportunities are more widel…

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 caused by …