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Postmarketing surveillance studies remain unethical
- Charlotte Paterson (23 October 1998)
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Charlotte Paterson
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When is a research study not a research study? When it is a postmarketing surveillance study conducted under the safety assessment of marketed medicines (SAMM) guidelines. Otherwise it would require ethical committee approval, wouldn't it, and as Ayres et al point out 1 this is not the case. Presumably this is why the authors ask us to believe that in this ‘non-interventional observational ' design general practitioners decided, purely on clinical grounds, to prescribe one patient the standard salbutamol inhaler and the next five patients the inhaler just released onto the market, and that this decision had nothing to do with the fact that he/she was being paid for each patient entered into the study. The patients gave their written informed consent for information to be extracted from their notes, but it is unclear how much they were told. In December 1997 I was invited to take part in a postmarketing surveillance study under the SAMM guidelines to assess the safety of Irbesartan in comparison to Amlodipine when administered for one year to mild to moderate hypertensive patients. This was ‘an open, observational cohort study' and it was planned that 1500 general practitioners would each recruit and follow up an average of eight patients for which they would be paid a total of £420. It was stressed that patients should be identified only after the prescribing decision had been made, and that it was not necessary to tell the patients that they were part of a study. The prescribing decision that I would have taken, on clinical grounds, was to prescribe the newly released Irbesartan to three patients and then to prescribe Amlodipine to one patient before again prescribing Irbesartan to three patients. Irbesartan is not included on any published hypertension treatment guidelines and at that time 28 days treatment cost £17.22, compared to 14p for bendrofluazide and £1.49 for atenolol. Both of these studies lead me to the same conclusions. A postmarketing surveillance study IS research. It is research in which treatment decisions are made for research purposes without fully informed consent and in which doctors, by pretending that their prescribing decisions are normal clinical practice, betray their patients' trust. If general practitioners must get involved in such studies, at least we should insist that ethical committee approval is required. 1.Ayres JG, Frost CD, Holmes WF, Williams DRR, Ward SM. Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines. BMJ 1998;317:926-30. Yours sincerely Charlotte Paterson General practitioner Warwick House Medical Centre Upper Holway Road Taunton TA1 2YJ |
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