I attended this valuable talk in a very good conference organised by CEP. This story shocked me as my daughter Karen, suffered a severe onset of psychosis and serious skin reaction, on the same drug Professor Abraham said killed 107 Americans in 1937. Now called Sulphasalazine (Sulfasalazine) the regulators refused to include psychiatric side effect of psychosis following my campaign and request in person at a meeting with the MHRA powers that be (Including Dr June Raine). Her comment was they would only add a serious side-effect (Adverse Drug Reaction or ADR) if there are enough ' Yellow Card' reports. I asked " How many reports they needed" (they already listed 9 cases on their web data). The response was " There is no set number" . I am horrified as I had an email from a Consultant Rheumatologist and will repeat his words here " I am to do a presentation on the psychiatric adverse events related to Sulphasalazine - I have seen at least 4 patients in the last 3 years. " He was trying to find statistics in order to draw attention to this serious omission in the data provided with the drug. If I had know this was a side effect, the moment Karen had the first sign of intolerance, terrifying nightmares, I would have stopped her taking the drug. Instead we had the trauma of a missing daughter and later once found and recovered from the mental side effect, her skin fell of her back when she 're-challenged the drug by taking just one 3 gram tablet" Recognised as a serious ADR she was warned never to take this again by a dermatologist. However the consultant still denied her mental illness was anything to do with his prescription of sulphasalazine for what he thought was Crohn's Disease (found later to be a misdiagnosis). When I asked if the breakdown could have been caused by the drug, he retorted " Only if she got dehydrated". That was a eye opener as we had no idea of the risks (in 1985 i had little knowledge of risks of medication and the industry did not have to provide any written data for patients until the EU directive in 1997 for Patient Information Leaflets to be with all prescribed drugs). The consultant even prevented my complaint to Pharmacia some years later (following Karen's early death at the age of 30). He wrote to Pharmacia with my report " The girl was depressed anyway". Well why did he do that.? She had never been diagnosed as depressed and was a uni taking her first year exam. Pharmacia had a right to report to the CSM as it was then called but did not. I deliberately followed through to check how the data is compiled and realised it is not compiled !! Anyway if you want to know more, I did a Spoken Word presentation at the Edinburgh Festival in 2019. If you go to Events on my charity web site you can read the story of Karen's ten years of intolerance and why I founded www.april.org.uk with plenty of other information I have gathered since 1998 until today. Millie Kieve