Cardiovascular diseases and the search for more evidence
Daniel Day Lewis won an Oscar this year for his depiction of Abraham Lincoln’s role in the abolition of slavery in the USA. As I watched Lincoln on the plane crossing the Atlantic, I wondered how many inequalities still exist in health and whether laws are the best way to reduce or abolish these inequalities.
Looking at just cardiovascular diseases, inequalities have been highlighted at local, regional, national and international levels, whether on the basis of gender, age, socioeconomic status or race. We have known about the major risk factors which cause cardiovascular disease for over 50 years, and yet some of these inequalities still pose significant challenges in many parts of the globe. An example from the UK is the recent study showing regional variations in mortality from cardiovascular disease in each electoral ward.
So do we not have enough evidence to act? Do we need to keep producing more research to show that inequalities and variations still exist? Of course, the answer is that we need to keep producing evidence, not just to understand the causes, “the causes of the causes” and in order to plan the best strategies to tackle these inequalities. Moreover, the evidence needs to be presented in new ways to reach the hearts and minds of policymakers in order to enact change.
In Circulation this week, Ezatti and colleagues consider the effect of macroeconomic changes on cardiovascular risk factors over time at the global level for hypertension, diabetes, hypercholesterolaemia and obesity. At the country level, systolic blood pressure, total cholesterol and body-mass index were positively associated with gross domestic product (GDP) and Western diet in 1980, whereas only total cholesterol remained positively associated with GDP in 2008. In an accompanying editorial, I make the point that existing surveillance systems for cardiovascular disease and its risk factors at global level are inadequate. This week, I am at the American Heart Association Cardiovascular Epidemiology and Prevention Meeting in New Orleans, learning about new data and new ways of presenting the data regarding cardiovascular diseases. Relating changes in cardiovascular disease to economic and macroeconomic change seems a promising strategy to get the attention of policymakers.
Astronomy and Evidence: StaR Gazing for Children's Trials
On the eve of the 20th anniversary of the United Nations Convention on the Rights of the Child, which recognised the right of all children to "the enjoyment of the highest attainable standard of health", the editor of the Lancet Richard Horton was delivering a plenary address at the first summit of StaR Child Health in Amsterdam in 2009. In his address, he stated the:
“Lack of research, poor research, and poorly reported research are violations of children’s human rights.”
Individuals from various disciplines, including the World Health Organisation, the US Food and Drug Administration, and the European Medicines Agency, gathered together to discuss a topic of shared interest: the paucity and shortcomings of paediatric clinical trials.
The quality, quantity and relevance of data involving children are substantially lower than those involving adults. This problem persists despite knowledge that inadequate testing of medication in children may result in harmful or ineffective drugs being offered or beneficial drugs being withheld.
Indeed a systematic review sponsored by the World Health Organisation found that there were few guidelines relevant to the design, conduct and reporting of research in children. Most guidelines only seem to focus on what should be done, failing to address the important issue of how it should be completed.
The mission of StaR Child Health is to improve the design, conduct and reporting of "research with children through the development and dissemination of evidence-based standards."
How best to achieve this monumental task? The StaR Child Health group is using a "knowledge to action" process that involves using a systematic process to review the current knowledge base, identify gaps, develop guidance and implementation strategies. An ambitious agenda that is gaining tremendous momentum.
Based the results of a systematic review and survey of key stakeholders, they have identified 10 priority issues. Each issue will be systematically addressed by a standard development group that will produce evidence summaries, identify gaps and develop a dissemination strategy. The priority issues include recruitment and informed consent, risk of bias, sample size, age-specific dosage and administration, safety and global health.
But more guidelines and standards will not change the conduct of trials unless they are implemented. StaR Child Health is leading in knowledge translation by involving multiple stakeholders from the beginning and is working with international partners, such as the GRIP Project, a global research network in paediatrics.
For the quality of health care for children across the world to improve, trials must be conducted that address the complexity of child health and provide reliable evidence-based answers. Now we can be confident that we have a bright StaR illuminating the path forward.
Do words speak louder than actions? Reflections after the summit.
I deliberately resisted blogging about it for a whole month, partly because I wanted to see the build-up and the aftermath of it, and partly because I wanted to see what everybody else said about it. I am, of course, talking about the UN High Level Meeting for non-communicable diseases (NCDs) on 19th and 20th September. The only other occasion that the UN has met like this on a health issue is for HIV/AIDS. The stakes were and are undoubtedly high and momentum has gathered and continues to gather. Yet there is definitely a sense of anti-climax after the summit. The organisation and run-up to the meeting seems to have been dogged by logistical but more importantly, by blocks through governments and multinational companies concerned about hard outcomes from the meeting.
I followed ex-BMJ editor, Richard Smith’s blog keenly throughout the meeting. It does not seem like the key stakeholders were invited or asked for opinions in time. As he said, probably the best thing to come out of the meeting and the pre-meeting is the NCD Alliance, a robust organisation of all the important stakeholders joined for the common purpose of raising awareness.
There is no question that awareness has been raised, and the summit was covered by medical journals, including the Lancet and the BMJ. Interestingly, the major American journals were notable by their silence on the first NCD summit of its kind. Yet, these same journals are the first to publish trials of expensive therapies for cardiovascular diseases, often with major conflicts of interest. On the subject of conflicts of interest, there are particular concerns about NCDs and the way big company interests are still able to play a major role in the UN.
The newspapers and other press gave coverage, but not as much as one would hope. Some of the loudest calls for actions came from celebrities such as Jamie Oliver. Looking around the WHO website, I did not find much in the way of concrete outcomes.
During my clinical cardiology practice, I have asked doctors and patients in the last few months if they knew that the meeting was happening. Almost without exception the answer was “no”.
On the second day of the summit, Richard Smith depressingly concluded:
“The big failures for me have been the failure to raise understanding of NCDs among the wider population and—as discussed at this morning’s meeting—the failure to recognise the need for a system that has at its centre patients not professionals.” It does not come much more damning than that.
What is the point of global health and health policy if it is not engaging at all with end-users? At the BMA Global Health event last week, I could not help feeling that this is an issue across global health and health policy-makers. Words are important but so are actions, particularly if the global fight against NCDs is to succeed.