These data will come as no surprise to anyone familiar with what many users have been saying on this and other websites, for several years. Enough people are reporting they get into extreme difficulties when they try to stop taking SSRI antidepressants to be certain of the risk that many more users are taking them basically because they can't stop.

Against this background, the response of the European regulatory system seems astonishing. Three years after taking up the issue - as a direct response to the concerns expressed on this website - the authorities have just produced a policy paper which muses about the need to conduct batteries of studies on animals in order to confirm or deny the ample experience of withdrawal and dependence in human users.

The paper represents the work of experts in the European Medicines Evaluation Agency (EMEA) and the Committee on Proprietary Medicinal Products (CPMP). They mention the possible need for studies involving "rats, mice, marmosets and dogs", but they are not sure which: "the right species have to be found, as some species might response differently (sic) to compounds as compared with humans".

The collective response of the Member countries represented in EMEA and the CPMP makes it clear that the manufacturers have yet to provide reliable evidence of lack of dependence risk. Ten years downstream of paroxetine, the regulators are now just thinking about requesting (but not requiring) both pre-clinical (animal) and clinical studies to establish that patients may get hooked.

This lack of evidence is worrying, but the official response is almost surreal. It seems inconceivable that animal studies could tell us anything much more than the data and evidence now available from scores of millions of users worldwide. The proposal to sacrifice some animals may be best understood as some gesture of faith or atonement, offerings to the Gods of Hope and Delay.

Why focus on animal studies when clear evidence of physical dependence and withdrawal phenomena is increasingly reported in new-born and premature infants, after exposure to SSRIs in utero? (Spencer, 1993; Kent & Laidlaw, 1995; Chambers et al., 1996; Mathew, 1996, Dahl et al., 1997; Mathew, 1997; Wisner et al., 1999; Mohan & Moore, 2000; Yapp et al., 2000; Nijhuis et al., 2001; Einarson et al., 2001). What better models of withdrawal distress, and of the potential of these drugs to cause physical dependence, could there be? Neonatal withdrawal has everything to do with the properties of the drug and nothing to do with relapse into depression.

If the experts and authorities aren't getting the message from babes, sucklings and other humans, it seems too much to expect them to gain or learn anything much from experiments with animals. The EMEA/CPMP need to consult and listen to users and then think again.

	Contents page
	Correspondence with government

                    e.g.   http://paxil.bizland.com    http://www.effexorfx.freeuk.com      http://www.drugawareness.org    http://www.pssg.org