It takes a lot to shock me nowadays, but I admit to being shocked by an article in todays Irish Independent. It reported here that cheese advertisements will have to carry a health warning in order to limit intake under new restrictions on advertising to children. Cheese will carry a health warning as part of a bid to tackle childhood obesity; yet antidepressants are handed out like bloody smarties and your friendly GP will not give you a health warning on the doubling of suicide and violence risk? That makes no sense.
Under EU legislation, Ireland does not permit ‘direct to consumer’ (DTC) advertising for prescription products. This is unlike in the US and New Zealand where DTC advertising is permitted. In the case of a TV advertisement in the US, it must include a “major statement” for prescription drugs. A major statement must include a ‘spoken’ presentation of the drug’s most important risks. According to the Food and Drug Administration (FDA), this must be done in a way that is clear, conspicuous, and neutral. In addition, they must include either every risk or provide enough sources (adequate provision) for the audience to obtain the drugs prescribing information.
EU advertising restrictions must mean that Irish broadcasting must be safer for the consumer, right? Actually, it doesn’t seem so. Last week I watched an Advert on TV3 regarding ‘Centrine Allergy’ which is an ‘over the counter’ antihistamine made by Rowex pharmaceuticals in County Cork. Considering there was no listed side-effects, this advert seemed to imply that Centrine Allergy is pretty harmless, so I looked up the patient information leaflet (PIL). The possible adverse effects of taking this antihistamine include depression, hallucination, aggression, extreme fatigue, agitation, rapid heart beat, swelling, changes in liver function,weight increase, convulsions, confusion, difficulty in sleeping, difficulty focusing, blurred vision, unusual eye movements, fainting, tremor, tics, pain and/or difficulty passing water and memory loss.
It could be argued that this medication should not have OTC status considering the dangerous side-effects which can occur with consumption. Surely the advert should, at the very least, include the serious side effects above? What about the safety of the unborn baby? Surely pregnant women should be advised, that as Rowex admit to ‘limited experience’ within pregnancy, their advise is to ‘use with caution’, and further, that Centrine allergy should not be used during breast-feeding.
I sent off a complaint to TV3 and got a swift response the following day. The response included “The advertisement to which you refer is entirely in accordance with all relevant regulation. There is no requirement under regulation to include all the possible side-effects of a medicinal product in an advertisement” and “the advertisement clearly states through text at the bottom of the screen, that you should always read the label and to ask your pharmacist for further information. There was no attempt to mislead the public about the possible side effects of this medicine.” If this is the case, and there is no requirement to include all (or any) side effects with DTC pharma advertising, the regulations need further regulating! I sent my complaint and the TV3 reply on to the Broadcasting Authority of Ireland (BAI), so we’ll have to wait and see what happens next.
Centrine Allergy PIL here.
While I was trying to find the advertisement to record, I came across this one above, advocating for the ‘early diagnosis and treatment’ of Arthritis. It recommended sending off for a free information pack to ‘Arthritis Ireland’. Note the Pfizer logo on the bottom right. It seems their latest campaign to ‘raise awareness’ is in partnership with Pfizer, who just happen to be seeking EMA approval for their new Arthritis medication; now there’s a surprise! In Nov 2012 the FDA approved Pfizer’s Xeljanz (Tofacitinib) for patients with Arthritis. The EMA though rejected Pfizer’s initial application, concluding that the serious side-effects such as liver damage, certain cancers and gastro-intestinal perforations, meant that the ‘benefits did not outweigh the risks’. Pfizer was not to be deterred. Dr Yvonne Greenstreet, Pfizer’s senior vice-president of medicines development, stated “The re-examination process will enable us to seek to address the CHMP’s questions, and we will continue to work closely with the EMA with the goal of making this medication available to the appropriate patients in Europe.” Hmm; I get the feeling that ‘Arthritis Ireland’ is being used as a pawn by Pfizer in the EMA approval process. Only time will tell!