Competing interests Jaideep A Gogtay MD Conflict of Interest Employee of Cipla Ltd
Appetite suppressant drugs and the risk of primary pulmonary hypertension Although physicians and patients need to be informed, the possible risk of pulmonary hypertension associated with dexfenfluramine is small and appears to be outweighed by benefits when the drug is used appropriately. NEJM 1996;35:609-16NEJM 1996;335: OR:23.1 ( )
What does competing (conflict of) interest mean? Set of conditions in which professional judgment concerning a primary interest (e.g. patient’s welfare or validity of research) tends to be unduly influenced by a secondary gain (e.g. financial gain) Condition, not behaviour
Who has competing interests? Physicians Scientists/Resarchers Teachers/Scholars Reviewers Editors Conflicts of interest are universal
Professional interests Profession 1 o interest 2 o interest Physician Patient care Monetary, Prestige Researcher Generation Publication of knowledge and funding Companies New therapies Trust Monetary Acceptance Journals Dissemination Impact factor of authentic Subscription information
Professional interests Profession 1 o interest 2 o interest Physician Patient care Monetary, Prestige Researcher Generation Publication of knowledge and funding Companies New therapies Trust Monetary Acceptance Journals Dissemination Impact factor of authentic Subscription information
Conflicts of interest are universal Doctors – Investigations – Admission to a particular hospital – Carry out treatments (drugs, procedures) – Own a hospital Doctors and Pharmaceutical/Biotechnology companies – Paid consultants to a company – Received research grants/travel grants – There are very few doctors who have not been given anything by a pharmaceutical company
Conflict of interest in the debate over calcium channel antagonists and MI NEJM 1998;338:
JAMA 1998;279:
Conflicts of interest are universal Scientists – Idea/Patents Journals – Reprints e.g. VIGOR study showed that Rofecoxib had less GI adverse events; 1 million reprints purchased by the sponsor (profits of 600,000 USD) – Advertisement revenue Personal (non-financial) – Relationships with individuals involved in submission of a paper (Friend, spouse, ex-boss/mentor, adversary) – Convictions (religious, political, ideological or other) Opposed to emergency contraception
Declaration of interest Nicholas Wald and Malcolm Law have patents for the Polypill (in EU countries and pending in USA and Canada. Priority date 10 April 2000)
Conflicts of interest are universal Scientists – Idea/Patents Journals – Reprints e.g. VIGOR study showed that Rofecoxib had less GI adverse events; 1 million reprints purchased by the sponsor (profits of 600,000 USD) – Advertisement revenue Personal (non-financial) – Relationships with individuals involved in submission of a paper (Friend, spouse, ex-boss/mentor, adversary) – Convictions (religious, political, ideological or other) Opposed to emergency contraception
Conflicts of interest are universal Scientists – Idea/Patents Journals – Reprints e.g. VIGOR study showed that Rofecoxib had less GI adverse events; 1 million reprints purchased by the sponsor (profits of 600,000 USD) – Advertisement revenue Personal (non-financial) – Relationships with individuals involved in submission of a paper (Friend, spouse, ex-boss/mentor, adversary) – Convictions (religious, political, ideological or other) Emergency contraception
Is it a bad thing? Conflict of interest per se is not intrinsically bad Represent situations in which interests of partners may not fully overlap Not judging moral character
Conflicts of interest need to be regulated (not self regulation)
Critics Questions their ‘scientific integrity’ Physicians say that decisions about patient care are not influenced by financial incentives Unfairly punish ethical physicians and researchers for the misdeeds of a few
Purposes of regulations regarding conflict of interest Maintain integrity of professional judgment – Minimize the influence of secondary interests Maintain confidence in professional judgment – People should continue to have faith in decisions – Distrust of the profession Failure to avoid conflict of interest may be wrong even when one is not influenced by secondary interests
The most important health-care development of the day is the recent, relatively unheralded rise of a huge new industry that supplies health-care services for profit. Hospitals and nursing homes, Diagnostic laboratories, Home-care and emergency-room services, Dialysis This new "medical-industrial complex" may be more efficient than its nonprofit competition, but it creates the problems of overuse and fragmentation of services, overemphasis on technology, and "cream- skimming," and it may also exercise undue influence on national health policy. In this medical market, physicians must act as discerning purchasing agents for their patients and therefore should have no conflicting financial interests. NEJM 1980;303:963-70
Conclusions??? Almost inevitable Full disclosure: Financial/non financial – Authors – Reviewers – Editors Evidence based medicine – Quality and level of evidence