Education And Debate

An Ethical Debate Financial ties as part of informed consent to postmarketing research: Defining surveillance

BMJ 1995; 310 doi: https://doi.org/10.1136/bmj.310.6995.1662 (Published 24 June 1995) Cite this as: BMJ 1995;310:1662
  1. Malcolm Vandenburg,
  2. Ian Dews
  1. IBRD Rostrum, Romford RM7 9QD Malcolm VandenBurg, chief executive officer.

    The authors of this study seem to confuse postmarketing surveillance and phase IV trials. Phase IV trials are interventional studies yielding efficacy, dosage, safety, and pharmacoeconomic data to supplement those available at the time of licensing. They are analogous to phase II and III studies and raise no separate ethical or financial issues; the doctor who had received $5000 per patient was doubtless undertaking such a study.

    Postmarketing surveillance, in contrast, uses non-interventional cohort observation to collect large scale safety data from routine clinical use. Patients are accumulated through normal prescribing, not actively recruited. No special examinations or tests are performed. The doctor's work is limited to passive reporting and the remuneration is therefore much less; the doctor who had received $5 per patient was clearly taking part in a postmarketing surveillance study.

    When respondents were asked to estimate appropriate remuneration, which type of study were the authors referring to? Estimates based on a complex interventional trial are irrelevant to simple postmarketing surveillance and vice versa. And what of the doctors and patients with no research experience at all? They were presumably answering from unfettered imagination.

    The belief that postmarketing surveillance is a thinly veiled marketing tool is largely confined to observers outside the world of pharmaceutical marketing. The principle of good marketing is to identify the customer's needs and to meet them. “Market seeding” studies with free, open label drug and large payments for scientifically invalid “results” were outlawed years ago. The pressure to set up a modern surveillance is more likely to come from the regulatory authorities than from the marketing department.

    The size of the payments made to participating doctors has long been a thorny issue. The 1988 quadripartite guidelines referred to by La Puma and colleagues stipulated a scale of payment that many thought was insultingly low, and the reluctance of doctors to work for almost nothing became a serious obstacle to recruiting enough doctors to complete large postmarketing surveillance programmes. The new quintapartite guidelines introduced last year addressed this problem in some degree,1 but participation in surveillance can hardly be regarded as lucrative.

    American and European regulations subject phase IV studies to independent ethical approval and to informed consent by the patient. In Europe the ethics committee must be told of the financial arrangements and can reasonably be expected to bring to the issue knowledge and experience beyond that of the typical patient. The committee must also approve the informed consent document and could therefore insist on the inclusion of financial information. In practice, it rarely finds this necessary.

    When safety data are collected anonymously from patients not subjected to specific interventions, neither ethical approval nor informed consent is necessary. What then of the doctor's conflict of interest? Postmarketing surveillance fees are essentially no different from any other form of item of service payment. Why would a participant in the postmarketing surveillance programme be expected to behave less ethically than a general practitioner with a vaccination target or a surgeon in private practice?

    Paying doctors for postmarketing surveillance is a logical necessity. If large scale safety data are to be collected, non-interventional surveillance is needed; only doctors are in a position to undertake this; they are as reluctant as anyone else to work for nothing.

    References

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