Rapid Responses to:

LETTERS: Jan P Vandenbroucke Case reports of suspected adverse drug reactions: Case reports were dismissed too quickly BMJ 2006; 332: 488 [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

Funding for hypothesis-testing studies

Mira Harrison-Woolrych   (1 March 2006)

Funding for hypothesis-testing studies 1 March 2006
Mira Harrison-Woolrych, Director, Intensive Medicines Monitoring Programme University of Otago, Dunedin, New Zealand Send response to journal: Re: Funding for hypothesis-testing studies	I have followed with interest the correspondence following publication of the Loke et al paper regarding case reports of adverse drug reactions (1). Although this paper concluded that case reports in pharmacovigilance have limited value, it has subsequently been agreed that case reports/series are valuable as hypothesis-generating papers and that clinicians and patients benefit from these reports. I would add that the number of follow-up studies is only one outcome by which to judge the value of case reports/series, but other outcomes may be more difficult to study. Whilst case reports are valuable in pharmacovigilance, there is no doubt that hypothesis testing studies are necessary and I agree with JP Vandenbroucke that a more consistent scheme is needed (2). An important question is where will funding for such studies come from? Pharmaceutical companies may have little incentive to further investigate adverse reactions and if funding is provided there may be conflicting interests. For different reasons, governments may also be reluctant to fund pharmacoepidemiology studies (3). Here in New Zealand, the government-funded Intensive Medicines Monitoring Programme (IMMP) performs hypothesis-testing studies which further investigate adverse drug reactions, including calculating incidence and identifying patients at risk (4). The IMMP was established in 1977 when it was recognised that spontaneous reports were insufficient to detect and fully evaluate adverse drug reactions. In its almost 30-year history, the IMMP has performed many valuable studies and is internationally respected (3) yet its future remains uncertain. At the time of writing (March 2006) none of the IMMP staff has a contract beyond 30 June 2006. It is still not known how the IMMP will contribute to the new Australia New Zealand Therapeutic Products Agency (5). In the meantime, important pharmacoepidemiology studies are at risk of not being completed, with loss of valuable data contributed over many years by patients and doctors throughout New Zealand. I give these details to make this point: the agreement that hypothesis-testing studies are required as a component of pharmacovigilance must be backed by a commitment to adequately fund such work. 1. Loke YK, Price D, Derry S, Aronson JK. Case reports of suspected adverse drug reactions--systematic literature survey of follow-up. BMJ 2006; 332:335-339. (11 February) 2. Vandenbroucke JP. Case reports of suspected adverse reactions (letter). BMJ 2006 332:488 (25 February) 3. Herxheimer A. Open letter to Annette King, Minister of Health New Zealand (letter). BMJ 2004; 329:51 (3 July 2004) 4. Harrison-Woolrych M, Coulter DM. PEM in New Zealand. In: Pharmacovigilance (second edition). Editors Mann R, Andrews E. Chichester, John Wiley and Sons, England 2006, in press. 5. Australia New Zealand Therapeutic Products Authority website available at: http://www.tgamedsafe.org Competing interests: I am the Director of the New Zealand IMMP