Has the hunt for conflicts of interest gone too far? YesBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39493.489213.AD (Published 28 February 2008) Cite this as: BMJ 2008;336:476
- Thomas P Stossel, professor
- 1Department of Medicine, Harvard Medical School, Translational Medicine and Hematology Divisions, Brigham and Women’s Hospital, 1 Blackfan Circle, Karp 6, Boston, MA 02115 USA
Most of us politely ignore street evangelists urging us to repent of our sins. Bizarrely however, academic medical administrators base policy on such preaching by anti-business activists. Their sermons, echoed by medical journals and the news media, warn that medical practitioners, educators, or researchers accepting gifts from or payments for services to companies producing medical products compromise their scientific objectivity and professionalism. Strangely, financial transactions between patients, insurance companies, hospitals, and doctors, encompassing 85% of the medical marketplace, do not count as conflicts of interest.
To be sure, corporations, like everyone else, sometimes behave badly and are punished. The key question, however, is whether detailed disclosure of conflicts of interest and stringent prophylactic management are in the public interest. I believe the answer is a resounding no.
Increasingly, conflict of interest policies exclude conflicted experts, however qualified, from writing reviews or editorials in some journals or from advising regulatory bodies on product approvals.1 They also limit or prohibit financial rewards professionals can receive from private companies for their work or even ban corporate consulting entirely. Other rules require academics to audit corporate research and eliminate commercial detailing, gifting, and samples.
What the conflict of interest movement does not yet regulate it maligns. It demonises “speakers’ bureaus,” which organise doctors to provide company sponsored education, and ghostwriters, accusing professional writers hired by companies of routinely creating promotional fiction that is allegedly legitimised by honorary academic authors.
The most extreme rationale for conflict management is that companies distort evidence and flout safety to promote products without substantive benefits and probable harms.2 A case in point is activists’ insistence that the events leading to Merck’s withdrawal of rofecoxib resulted from deliberate deception motivated by profit3 rather than, as most juries addressing rofecoxib related litigation concluded, from bad luck and inadvertent error.4
By juxtaposing examples of overt research misconduct by academics with nocorporate ties against far less heinous cases in which researchers failed to honour overblown journal disclosure requirements for corporate support, proponents of conflict of interest insinuate that research sponsored by companies is biased or even fraudulent.5 The “no free lunch pledge” states: “I am committed to practising medicine in the interests of my patients and on the basis of the best available evidence, rather than on the basis of promotion,”6 implying that corporate promotional information is not evidence based. Therefore, doctors freely mingling with or listening to corporations may be ill advised, corrupt, or both.7
All of these charges obscure the overriding fact that only private companies bring new products to patients and that medical care has improved steadily and spectacularly because of them.8 Fraud and pathological bias could never have conferred these monumental achievements.
Lack of evidence
Conflict of interest ideology purports to promote scientific rigour yet is far from rigorous itself. Adverse outcomes objectively ascribable to financial conflicts of interest are almost non-existent, especially in the context of overwhelmingly positive commercially driven medical advances.9 Conversely, purely academic research and education are hardly more reliable than their corporate or corporate sponsored counterparts—arguably less so, because they are not, for example, subject to stringent Federal Drug Administration reporting requirements. Misconduct fells a single academic miscreant but can bring down an entire company.
No evidence supports that corporate detailing and gifting adversely affect patient care.10 Yet anti-business critics baldly misrepresented this fact and have not retracted or corrected the error.11 Medical journals waste space on meaningless compilations of who receives what payments from companies and dubious “social science research” purporting to prove that most doctors lack the intelligence or character to be wary of promotional claims.12
Damage to research
These attitudes and regulations are not only ill founded but also manifestly harmful to the public’s interest in medical innovation. The management measures exclude the best experts from providing education and advice, cost time and money, and are deeply disrespectful of physicians and researchers. Corporate compliance bureaucracies, fearful of regulators, have refused to renew funding for successful continuing education programmes on the grounds that this success automatically connotes promotion of company interests. Investors have told me that conflict of interest regulations that limit investigator equity inhibit establishment of new companies based on academic technologies. Conflict of interest scolding also promotes distorted and damaging views of science and medicine: it portrays science as devoid of subjectivity and passion and the medicine as irrationally walled off from commercial society.13 14
Most passers by who ignore street corner preachers are decent, generous, and reasonable, as are most doctors. They realise that asceticism and utopian zeal for behavioural perfection produce nothing and that risk taking entrepreneurs, motivated in part by profit, advance medicine. They do not want pious bureaucrats regulating their rewards or telling them with whom they can associate. Physicians and researchers working in the real world can restore common sense and balance by overcoming their inertia and fear to resist the unproductive and hitherto unopposed conflict of interest alarmists. As a step in the right direction, the University of California System’s Academic Senate recently soundly rejected intrusive conflict of interest regulations as vague, overbroad, addressing perceived rather than real concerns, and in violation of academic freedom.15 Others should follow this enlightened lead.
Competing interests: TPS is on the boards of directors and owns stock options in ZymeQuest and Critical Biologics Corporations, and his employer has licensed intellectual property to these companies, which may result in his receiving milestone payments, royalties and in the stock options having financial value. He receives fees for speaking to corporations and other organisations on the topic of conflict of interest. He has served on scientific advisory boards for Biogen, Dyax, and Merck.