Ritonavir (Norvir) & Ecstasy (MDMA) Interaction - Inquest Verdict
My boyfriend, Philip Kay, died on 6th October 1996. Following an autopsy and toxicological investigations, the cause of death was shown to be an overdose of MDMA, the main chemical ingredient of Ecstasy.
Although I was confident that Philip had only taken two and a half tablets, Phil was found to have 4.56 mg/L of MDMA in his blood. Plasma levels of this magnitude would be consistent with Phil having taken 22 tablets. Phil had used some of the same ecstasy tablets, with no ill effects, a few weeks earlier whilst on holiday. However, since returning from holiday, Phil had started on combination therapy and was taking Ritonavir (Norvir), a protease inhibitor produced by Abbott Laboratories, and I suspected that the high level of MDMA was the result of the effect of Ritonavir on his body's ability to metabolise MDMA. I pressed for this to be investigated further in order that any reoccurrence of the tragedy be avoided.
I sought the assistance of the Terrence Higgins Trust, who supplied legal representation, and in November I had the original inquest adjourned in order that further investigations be carried out.
Early this year, Abbott wrote to me and acknowledged that the interaction was theoretically possible and would - under normal circumstances - produce an increase of about three-fold in the levels of MDMA in the blood-stream.
I felt that if an interaction existed, that the best way to warn patients was at the point of prescription - perhaps on the patient info sheet - rather than leaving it to chance by leaving it to word-of-mouth or dependent upon the user having read this or that magazine.
Although Abbott Laboratories were willing to send out details of the danger to physicians - if following a request from their patient they contacted Abbott and asked for them - and despite pressure in the UK , the USA and elsewhere, they refused to make an unsolicited announcement for fear that this would be construed as an endorsement of the use of illegal drugs.
We felt that this was insufficient as this, of course, relied upon the patient admitting recreational-drug use and asking the doctor first. We had tried to publicise the interaction as much as we could and hoped that the Coroner's verdict would raise awareness further and maybe force Abbott Laboratories to include a warning on the drug packaging.
During Phil's inquest, (25th July and 15th October 1997) evidence was given by expert witnesses (including Dr. John Henry - late of Guy's Poisons Unit - UK's leading expert on Ecstasy)
The Court heard evidence, from Dr. Erica Allason-Jones (HIV Consultant - Bloomsbury Clinic UCLH) regarding Philip's health (which was good) at the time of his death, with particular reference to his recent Liver-Function-Tests. It was shown that although these had been abnormal during the previous two years, and were still high, they were in fact better than when Phil had last used ecstasy, and would not therefore be responsible for any sudden inability on Phil's part to metabolise MDMA.
Interaction and Window of Danger
After examining the evidence given, and following discussions with Abbott Laboratories (UK) the Coroner accepted that the interaction between Ritonavir and MDMA had resulted in a ten-fold increase in the levels of MDMA found in Philip's blood.
It was also noted that there was a period of particular danger immediately following the dosing-up schedule, when the CYP2D6 pathway in the liver which is responsible for metabolising both Ritonavir and ecstasy was almost completely blocked as it metabolised the Ritonavir. During this period, other substances using the pathway are left in the blood and could build up to potentially dangerous or fatal levels.
The Coroner told the court that she regretted the fact that she was forced by technicalities to return a verdict of 'death through non-dependent abuse of drugs'.
She commented that, having heard and read testimonies regarding Phil's nature and his reputations as a bit of a Mr. Sensible :)<grin> she was certain that had he been aware of the danger he would not have mixed the two drugs, and that because the whole episode was obviously a terrible accident, she wished that she were able to return a verdict of 'Accidental Death '
Warning of Interaction
The Coroner felt that Patients deserve to be warned of specific dangers, and rejected the notion that to warn people of an interaction would be tantamount to encouraging illegal drug use, and that Abbott's latest offer to include a general statement in the technical information they gave out would be too vague and easily missed, being buried amongst a sea of information.
She said that she could see no reason at all why clear and specific wording should not be put on the drug packaging warning people of the interaction between Ritonavir and Ecstasy. Furthermore, on this point she would be reporting the case to the Committee on Safety of Medicines under Rule 43 of the Coroner's Rules for further action.
On this point, Professor Henry also intends to take the case further by researching the circumstances of Phil's death and will be writing up a paper on it for the BMJ.
In a time when we are still all too familiar with the stories and tales of bereaved gay men and lesbians having their grief compounded by the treatment they receive at the hands of authorities - be they local or national government departments, multi-national companies, employers and the media - when their relationship to the deceased is belittled or unrecognised - I feel that it is only right and proper to mention that, in this case, DC Tony Stepney (Clapham CID), the Coroner - Selina Lynch - her staff and officials, at all times treated me with kindness, compassion and respect. I thank them for that.
I must also take the opportunity to send my heart-felt thanks to all those who have given me support, help and encouragement when dealing with this whole issue over the last year. Particular thanks go to the Terrence Higgins Trust, who supplied legal assistance( Steve Deutz, Jonathon Glasson and Alice Holt), as well as Ron Alcorn, David Miller and Dr. Erica Allason-Jones (all at the Bloomsbury Clinic UCLH), Annie (Ball405@aol.com ),Michael Brady, David Campbell-Morrison (ATP), David Concar (New Scientist), Spencer Cox (Positively Aware), Gay Times, Geoff Henning, Rachel Heylan (Chief HIV Pharmacist Middlesex Hospital UCLH), Edward King (NAM), John Labella (HIV Info-Web), Sandy Langley, Bronwyn McGuire, Bruce Mirken, Dominic O'Grady (Sydney Star Herald), RonniLyn Paul (POZ Magazine), Pink Paper, Sandy (POZMERE), Adam Shane (CATIE), Thud Magazine, Paul Ward and all at Positive Nation
I'd been together with Phil for ten years and this has been the most painful and profoundly damaging event of my life. so on a personal level, I thank all my friends and my own and Phil's family for their love and support during the last year. Special thanks must to Robin Kay (Phil's little brother), Sube Banerjee, Chris Gable and Tim Dennet in particular, without whose support I would have went-under long ago.
Jim Lumb <firstname.lastname@example.org>