The European Journal of Cardiology Published: 7 April 2012 Lois Rogers.
Following the recent European Society of Cardiology initiative,1 Lois Rogers reports on this important topic
Doctors, medical institutions, and governments themselves have been forced to recognize that conflicts of interest are beginning to shake public faith in the medical profession.
Some of these conflicts have led to corruption on a gigantic scale, most notably the revelation that the fraudulent author of the scare over mumps, measles, and rubella vaccine which began in the UK was being funded by a firm of lawyers intent on proving the vaccine had caused autism in a small group of children.
Other less dramatic incidents include that of cardiovascular researcher Don Poldermans of Erasmus University, Rotterdam, himself an ESC official, who was last year found to have fabricated data, though his motive was unclear, and no patients were harmed.
Two American doctors have even set up a blog called Retraction Watch.2They have not broken down reasons for research fraud by motive, so it is not clear how much malpractice is motivated by money, how much by the prospect of career advantage, and how much by a simple urge to bend the facts to make them fit a treasured hypothesis.
Heart disease along with cancer, diabetes, and obesity is, however, one of the most lucrative disease areas of this age. The rewards for skewing the agenda towards the use of particular treatments are considerable, and there are plenty of vested interests intent on doing so, some of which are undoubtedly of benefit to patients, and some of which are probably not.
The ESC has now set itself at the vanguard of professional medical bodies attempting to bring a new wave of transparency to the relationship between cardiologists, drug companies, and the manufacturers of medical devices.
It has declared that health-care providers, educators, professional associations, and industry must now take decisive and collective action to eliminate real or perceived bias.
It has published a white paper1 banning the presence of company staff on clinical guideline committees, the non-disclosure of company connections by authors of papers published in its journals, and the restriction of commercial input into continuing medical education.
Some outside observers might be dismayed, not to say astonished, that the influence of vested interests in the conduct of science has until now been so completely pervasive.
Those on the inside, however, point out it is inevitable. What they do acknowledge, however, is that if it is understood that interests are always declared, then conflicts will be transparent and much of the anxiety will disappear.
It is remarkable that only about half of the 40 000 scientific journals published around the world have any sort of policy covering the disclosure of vested interests.
Baroness Onora O’Neill, a Cambridge professor of philosophy and one of Britain’s leading authorities on issues of trust and transparency, points out that as a member of the House of Lords, the upper House of the British parliament, she has become entirely used to updating on a monthly basis her entry in the register of members’ interests.
She recognizes that most people in other fields are unfamiliar with the process, and if they try to do it at all, they often get lost in what relationships might represent a conflict and what might constitute a reasonable financial threshold to warrant declaration.
‘My experience is that most [scientific journals] are not trying to do it very actively, and for those that are, it is a disorganised cottage industry’, she said.
‘It would be most useful if the editors collaborated on a framework because then it would be transparent. If we had a standard form for declarations of interest then everyone would know what was expected and where they stood’.
It is a view shared by others. David Wood, professor of cardiovascular surgery at Imperial College, London, is the ESC board secretary who organized the meeting in Rome 2 years ago, which led to the development of the white paper. ‘In evaluating evidence for a drug or a device, it’s important that as scientists and clinicians, we are impartial’, he says. ‘If someone has a relationship with a company, then obviously there is a risk their advice will be biased. The drive towards disclosure of interests is an inexorable trend, and rightly so. Anyone not doing this is behind the times and will have to do so very soon’.
But should medical societies reject all industry subsidy and be funded by subscription only, thus excluding younger, impoverished scientists likely to have the best ideas, and should academic researchers boycott demands that they patent their discoveries and issue licenses to those undertaking commercial development, in favour of investigating areas of ‘pure science’ less likely to have a clinical application.
Regulatory authorities are increasingly requiring drug companies to disclose their expenditure on soft-soaping doctors. ‘As of this year, we have to account for every penny we spend on supporting doctors to attend conferences, and other related activities’, said a spokesman for the pharmaceutical giant Roche. ‘But if we don’t help them to go to meetings, who will. In the drive to clean everything up, we have to make sure we don’t go too far in the other direction and destroy the sharing of knowledge’.
Many others think it is unrealistic to think disclosure will make a big difference. ‘It’s a bit hypocritical to consider only financial conflicts of interest, and I think the importance of this is being overestimated’, said Tom Lüscher, editor in chief of the European Heart Journal and professor of cardiology at Zurich University. ‘If something is true it will be reproducible and survive the test of time’.
Only time will tell if he is right.
Lois Rogers, international commentator on health science and social policy issues
- ESC Board. Relations between professional medical associations and the health-care industry, concerning scientific communication and continuing medical education: a Policy Statement from the European Society of Cardiology. Eur Heart J2012;33:666-674.