Comment: Unpublished trial data may have influenced heart recommendations
Fletchers Solicitor’s Senior Medical Negligence Solicitor, Christian Beadell is concerned that heart treatment recommendations may have been influenced by unpublished material trial data.
Christian is commenting in response to a recent BBC Newsnight investigation into unpublished trial data linked to the management of left main coronary artery disease.
According to Newsnight, the unpublished data casts some doubt on whether the incidence of heart attack were as low as reported in patients with stents.
Whilst the information available is limited, it is highly concerning that material trial data may not have been published. Furthermore, that treatment recommendations may have been influenced by this omission.
For patients who have undergone stent surgery for left main coronary artery disease and then gone on to suffer a heart attack, there will consequently be fears that this could have been avoided if they had instead undergone open heart surgery.
Further investigation now needs to happen and the EACTS should conduct a thorough review of this new data and publish their findings.
In other words, if the unreported trial results change the overall advice, then the Guideline needs to be revised.
Incomplete data may be to blame
The heart guidelines were issued following the results of a three-year trial published in 2016.
The trial, which was sponsored by the US Stent maker Abbott, studied the outcomes of patients who had open heart surgery against those who had stents only.
Subsequently, outcomes were compared between the groups based on whether a patient went on to have a heart attack, a stroke or died.
After that, the study recommended that stents were used in low risk patients.
However, the European Association for Cardio-thoracic Surgery (EACTS) have expressed concerns. In addition, they now believe their recommendation may have been reached as a result of incomplete data.
If you have affected by this story, please contact Fletcher’s medical negligence team today on 0330 013 0251