(The story outlined below is authored by ‘Margaret’. Since this was first written there have been a number of developments and an update to ‘Margaret’s Story’ will follow – DH).
Our son went to his GP with poor sleep because of worries at work. His doctor said he was depressed and put him on a combination of Cipramil (SSRI antidepressant) and Temazepam (a sleeping pill). A week later he took his own life. We now question both the diagnosis and the combination of medications – a mixture of uppers and downers.
Many of those who take their lives have recently attended the doctor. It must be important to see if there are any links between the use of medication and death. In the time since his death we have had a steady correspondence with the Department of Health and MHRA in an attempt to clarify how anyone can come to be placed at risk of suicide from their treatment. We would consider ourselves to be well-informed but we had no idea that mind-altering drugs are prescribed so widely with negligible safeguards.
The system… is deemed to be adequate
Early on we discovered enough about Cipramil and other SSRIs to give us cause for concern. This has been the driving force behind our enquiries since. We have written to a succession of Ministers of Health and received replies from the offices of Andy Burnham and Mike O’Brien saying in effect that the current system, with regard to maintaining the best practice in the use of SSRI antidepressants, is regularly reviewed and is deemed to be adequate.
We were directed to the regulator, the MHRA, and this led to a back and forth between the MHRA and Department of Health and ourselves. We have been sent an abundance of correspondence that invariably buries whatever issue we address in a welter of references to complying with the European Union and the CSM Working Group, along with directions to seek further information at the NICE website or MHRA’s own website etc.
This is not acceptable for someone seeking advice in plain English to find that it isn’t readily available. There is no apparent will to put information about SSRIs in the public domain. It has to be sought out and cannot easily be found. Updated information, it seems, gets posted to locations not easily accessible to the public at large.
the unalienable right for all patients and their carers to know about risks
Virtually every time I have corresponded with the Department of Health or MHRA I have referred to the BNF guidance that:
“the use of antidepressants has been linked with suicidal thoughts and behaviour. Where necessary patients should be monitored for suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment or if the dose is changed”.
This two-sentence warning, and what I feel is the unalienable right for all patients and their carers to know about risks, has been at the heart of my enquiries. But it has never been addressed. The MHRA drew my attention to the NICE advice:
“Depression and anxiety commonly co-exist, and insomnia is a core symptom of depression. Whereas antidepressants usually take two to four weeks to take effect, benzodiazepines are effective anxiolytic and hypnotic drugs with an immediate onset of action. Therefore benzodiazepines could be expected to produce early improvement in some symptoms of depression, although they do not have an antidepressant effect.”
This advice ties together depression, anxiety and insomnia. It seems to direct the physician towards the use of antidepressants as a cure-all. The implication is that a benzodiazepine could help the patient initially until the antidepressant reaches a “therapeutic” level. But NICE does not recommend long term augmentation of antidepressants with benzodiazepines. As ever, the message is confused.
if the drugs take two weeks and more to work for good, then they take the same time to harm
The NICE advice, it seems to me, is being used as a fig-leaf to cover the failure to address the more dangerous period of early uptake or dosage amendment (which the MHRA choose to interpret as ‘at the point of increase’, not the dreadful time of withdrawal experienced by those with long-term repeat prescriptions who wish to stop, or those who do not sustain regular dosage). Significantly, NICE does not address the question of whether there are critical points in usage. It seems that so many interpret their advice as meaning that if the drugs take two weeks or more to work for good, then they take the same time to harm.
When, on the day he died, our son presented at an A&E unit, he saw a doctor who was not a psychiatrist. He was informed of our son’s medication details and has since stated that, although he was aware of the suicide risk of Cipramil he did not alert our son to this. Part of the hospital’s explanation for this lapse was adherence to the “two weeks to improve therefore two weeks to deteriorate” mantra embodied in the NICE advice.
Where this originally comes from is still a mystery. Our son was left without hope or insight that would have told him he was in a temporary state of crisis that could be addressed with proper medical assistance. The NICE advice is at odds with the BNF warning, and so conflicting messages are being sent to those seeking guidance.
all leaflets should contain a suicide risk warning
Much of our correspondence has centred on the failure of the PIL – the patient information leaflet – as a means of communicating risk. The MHRA assured me that all leaflets should contain a suicide risk warning, combined with the advice to appoint a relative or friend to read the leaflet and monitor the patient. I found that the Cipramil leaflet in my possession did not have the combined message. The suicide risk was mentioned, though not at all well highlighted. The advice to appoint a monitor was not there.
I received a grudging reply that steps were “being taken by the MHRA to ensure the PIL for this particular Citalopram [Cipramil] product is updated to include the full warning”. No acceptance that the current system fails and no wish to revise existing practices. I had wrongfully assumed that all PILs had to replicate a master produced by the MHRA for each drug – not so. There is no apparent will to raise the level of the suicide warning in the PILs for antidepressants.
When I asked why the two sentence advice from the BNF could not be in the public domain I was told that “it is not feasible to have a public campaign to inform all patients about the side effects associated with all of the medicines on the UK market”. I replied that SSRIs could be classed as a group and are used by so many patients that it was well worth circulating vital information about potential risks. I received no reply to this comment.
According to the Office of National Statistics, 39 million prescriptions were issued for antidepressants in 2009. Even factoring in a calculation for repeat prescriptions, the number of patients using antidepressants runs into millions. This establishes them as a considerable proportion of patients who need to be as well-informed as possible, given the suicide risk their medication can give rise to.
Who decides who lives and who dies?
I wrote to Anne Milton, Under Secretary of State for Public Health, expressing my concerns and dissatisfaction with the response of the MHRA and also copied the current Minister for Health, Andrew Lansley, into a letter I wrote to the MHRA. I was then switched to the Department of Health and I was told that the
“Department believes a balance has to be reached between raising awareness and deterring people from taking antidepressants which can and do prove to be very effective treatments …..”
This “effective treatment”, if it exists, is being achieved at the cost of the lives of a vulnerable minority, no reference to this of course. Who decides who lives and who dies – shouldn’t we know about these risks, especially when knowing about them means that more might live?
The Department believes that my concerns over public awareness have been well covered in the press and the scientific media. Really? The Department has deemed that
“the PIL is a patient aid and does not replace the discussion between the prescriber and the patient. It is good clinical practice to discuss the potential risks as well as the benefits of a treatment, prior to issuing a prescription”.
Plainly, nobody has told the prescribers this. It appears to me that ill-informed and pressurized GPs are just as much victims of the current failing system as the patients. The emphasis on targets has led to foreshortened consultation time and quick-fix prescription of medication.
in a bizarre twist I was directed towards the General Medical Council
Then in a bizarre twist I was directed towards the General Medical Council (GMC) by Department staff as “….the training and development of medical professionals is the role of the GMC.” The Department says it does not investigate the conduct of doctors but
“the GMC seeks to promote high standards and ensure that medical education and training reflects the needs of patients, the service, students and trainees. Your concerns about the lack of knowledge regarding antidepressants should also be directed to the GMC”.
I approached the GMC. They did not respond to my query as to whether or not the seemingly counteractive combination of antidepressant and sleeping medication is deemed to be accepted practice. They have chosen to deal with this as a fitness to practise issue and gave me a deadline by which time they wished to receive the names of the GP and A & E doctor involved in our son’s case. Otherwise they would assume that I wish no further investigation. I have refused to comply, as I don’t see the doctors as being to blame.
As a result the GMC now consider that they are not the best agency to deal with my concerns. I have been told that they “are not a part of the NHS or Department of Health and have no powers to affect generalized policies. Concerns about the system, that is NHS procedures or the way that medics are trained, does not generally fall within our remit.”
This seems to be a complete contradiction to the promise of the Department of Health that training and development of medics is in the remit of the GMC – they are talking totally at cross purposes.
the Department will be unable to enter into further correspondence with you on this matter
The GMC directed me to the Parliamentary and Health Services Ombudsman, our local MP and, ironically, back to the MHRA. Exasperating to say the least. The Department of Health meanwhile now tells me that
“unless there are any subsequent developments surrounding the labelling of UK prescription medications, the Department will be unable to enter into further correspondence with you on this matter.”
The authorities refuse to listen or respond. At a time when the situation is fluid and changing as more information emerges about adverse drug reactions, the authorities are set in concrete or stagnant. If you are not satisfied with their reply, then it is your fault and you are not to bother them again. This institutional heedlessness parallels the stance of the pharmaceutical companies when a patient is not responding well to their drug – it must be down to the patient and not the drug.
The system is failing patients and doctors. Doctors are not trained to look out for or to deal with adverse drug reactions. Medication is not accompanied by adequate patient information and the doctor is not instructed to outline clearly the potential dangers to the patient. We can’t improve the system unless we recognize the inadequacies.
Out in the real world, precious lives are being lost to horrific avoidable deaths.