Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
'FATALLY FLAWED' YELLOW CARD SCHEME
- Clifford G. Miller (7 May 2004)
-
Patients and adverse drug reactions monitoring in India
- Vikas Dhikav (10 May 2004)
-
Drugs Side Effects and patients!
- Dr. Naseem A. Qureshi, MD, IMAPA, LMIPS (12 May 2004)
-
YELLOW CARD SCHEME - not so flawed
- Nicholas D Moore (28 May 2004)
-
side effect reporting by patients
- John Madura (30 May 2004)
-
Re: side effect reporting by patients
- Claire E Jackson-Prior (6 August 2008)
|
|
|||
|
Clifford G. Miller, Lawyer graduate physicist former examining lecturer law standards ethics Beckenham Kent BR3
Send response to journal:
|
Richard Smith's editorial (1) is headlined 'Transparency: a modern essential'. That the public are right not to trust pronouncements of government officials and scientists and to treat them with scepticism is exemplified by the government hype this week announcing the 'Independent Review of Access to the Yellow Card Scheme'. The system of pharmacovigilance in the UK has been fatally flawed for a very long time. Drug scandal after drug scandal over the years has demonstrated this (2) such that for many victims, the Yellow Card Scheme can only be described over the past 40 years as a disaster, and that is despite the many medical professionals who will rush to praise it highly, ignoring its serious failings. The government has been embarrassed into rushing out, under cover of this review, dealing with making adverse drug reaction data more widely available, patient reporting of adverse reactions. Patient reporting is considered necessary because of continued massive under reporting of adverse reactions, which continues despite a previous initiative of the extension of the Yellow Card Scheme to nursing and pharmacists. Full marks to The Royal College of General Practitioners who commented (3) ‘.... the UK still lacks a comprehensive strategy and development plan for a complete system of pharmacovigilance and therefore the remit of the Yellow Card Review Group is too narrow in this context.’ and to Social Audit, whose careful work and research exposed the selective serotonin reuptake inhibitor (‘SSRI’) antidepressant ineffectiveness, suicide and addiction scandals (2), and whose careful and detailed comments on the review include that the ‘..... present operation appears .... “chaotic and misconceived” .... focussing on the detection of rare, esoteric, new adverse drug reactions - while purporting to monitor the impact of ADRs overall ...’ and further noting the failure to assess and communicate the uncertainty of risk, being, ‘at present ... slavishly geared to establishing the certainty of harm.’ The Health Minister Lord Warner and Professor Breckenridge, chairman of The Medicines and Healthcare products Regulatory Agency (‘MHRA’), both made statements in the DoH press release failing to mention any reason for the need for any review of the Yellow Card Scheme or for their slipping patient reporting, a data capture mechanism, into a review dealing with making data delivery more widely available. Instead they trumpet the Scheme as “of the best spontaneous reporting schemes for adverse drug reactions in the world” and “The Yellow Card Scheme has been the cornerstone of monitoring drug safety for 40 years. The data generated .... can be used to further research and improve drug safety ..... These proposals will help to ensure that the full potential of this data is realised. ....... work which will help make sure that the scheme continues to identify potential issues of drug safety. Whilst both of these gentlemen must know the truth, having the entire information resources of the Department of Health (‘DoH’) and government behind them, these statements underline the need for strong public scepticism of governmental and official ‘spin’. If the Yellow Card Scheme is ‘of the best ... in the world’ and ‘the cornerstone of .... drug safety for 40 years’ we can look forward to many new scandals in future and one can only wonder about what is happening elsewhere in the world. How refreshing it would have been if Tony Blair’s government could have just this once taken the opportunity to say that the Yellow Card Scheme has been useful, but has some deficiencies and it is hoped this review would go some way to address them. Spin yet again got the better of them and generates more distrust. It is clear from the responses to this review of the Yellow Card Scheme from pharmaceutical giants and some areas of the medical professions that there is a strong desire to keep the resulting adverse drug reaction data tightly under wraps and as far away from the public gaze as possible. A marvellous argument for generating and maintaining the growing public distrust and scepticism of drugs, drug companies, government and medicine is to keep the data as secret as possible. GlaxoSmithKline insist (3) that ‘provision of data is for research purposes only, and this occurs only after submission in writing of a research proposal and approval by a committee or panel ....’ which will be bound to hamper safety by almost totally preventing the release of fundamentally needed safety data to vast swathes of interested parties. But then, most research is carried out by drug company funded researchers so this will also ensure most of the data will be held in research controlled by drug companies (4). Spurious reasons are also given by respondents for this proposed secrecy, one of the main ones being ‘media scare’ stories. However, keeping the data hidden hitherto has not prevented media ‘scare’ stories, but has assisted them. The media also do not need anyone’s help to put out ‘scare’ stories; they will do that anyway whether the data is made available or not. Making the data widely available will, in fact, hamper such ‘scare stories’ and make it more difficult, not easier to justify them and will make it easier for many more medical professionals and others to attack unjustified ‘scare’ stories. It is also claimed in the responses to the review that the public will ‘misinterpret’ the data. Surely the most compelling argument in this vein for not allowing general public access is that the public already has Lord Warner, Professor Breckenridge, the Committee on Safety of Medicines, the entire DoH and numerous government scientists and drug companies, all there to misinterpret the data for them. This argument of misinterpretation also of course forgets that there are some highly qualified highly competent intelligent and skilled members of the public out there who can interpret the data themselves. They just happen to be dedicated medical professionals who do a great job for society every day and who are also questioning and sceptical of what the government and its officials and scientists say. Naturally, making this data available to the public, say, on the internet will encourage labourers, factory and office workers up and down the country to rush home every night, eager to surf the data and misinterpret it. Of course, they will all want to have incorrect interpretations and will completely ignore any valued analyses and opinions made available from sources the public will come to trust, when the data is made widely available. It is also unsurprising that the pilot scheme in Beckenham, Kent to allow patients to report side effects to NHS Direct, is reported by Dr Jeremy Metters, chairman of the steering committee for the review, to have had disappointing results, with only 39 reports since the project started a year ago. I can let Dr Metters out of his misery. He need no longer "speculate why participation has been so poor”. No one much here has heard of it. As a Beckenham resident and having been advised recently by a health professional to do so, I was wondering how, without troubling our excellent local GP service, I could report the peculiar rashes on one of my small children’s back and legs occurring immediately following the end of a ten day course of oral phenoxymethylpenicillin 125mg/2.5ml dose. I am still no wiser and the suspected reaction is still unreported. And then, why should I bother? I will probably never get to see the resulting data anyway to see whether there might have been other similar rashes? And my children will soon grow out of these things, it is hoped? Does this bode well for the outcome of this much hyped review? (1) http://bmj.bmjjournals.com/cgi/content/full/328/7448/0-f (2) A few recent examples are Seroxat/Paxil, Prozac and thioridazine (1). The latter example is startling because, despite it being a killer (J. G. Reilly, S. A. Ayis, I. N. Ferrier, S. J. Jones and S. H. L. Thomas. QTc-interval abnormalities and psychotropic drug therapy in psychiatric patients. Lancet 2000, 355, 1048-1052) and a certain cause of poisoning of the brain and nervous system leading to 4% per annum developing tardive diskynesia, by dint of such a flawed system it continued to be licensed for almost the entire 40 years that the Yellow Card Scheme has existed and the scandal never made the headlines - but then, it was only elderly and mentally ill who swallowed 450,000 prescriptions per annum and the odd death of an elderly or mentally ill patient from ‘heart failure’ (quoted consultant pathologist’s use of that term from one case) would most likely be recorded as ‘natural causes’. (3) Annex I ‘ 'Report of an Independent Review of Access to the Yellow Card Scheme' 4th May 2004 - TSO, PO Box 29, Norwich, NR3 1GN http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/yellowcard/accessreviewreport.htm (4) Pharmaceutical companies now finance and effectively control predominantly all medical scientific research. In 1984, in the USA, private companies contributed only $26 million to US university research budgets. By 2000, they were funding $2.3 billion, an increase of 9,000 percent. This was as a result of an amendment to U.S. patent law called the Bayh-Dole Act. Passed in 1980, Bayh-Dole for the first time permitted universities to commercialize products and inventions without losing their US federal research funding. This has fostered cozy relationships between the academics upon whom the world depends for unbiased medical information and private pharmaceutical companies whose main goal is making a profit. "Doctors Without Borders" by Shannon Brownlee, Washington Monthly April 2004 http://www.washingtonmonthly.com/features/2004/0404.brownlee.html Competing interests: Close relative with life threatening food allergy |
|||
|
|
|||
|
Vikas Dhikav, Resident All India Institute of Medical Sciences, New Delhi-110029, INDIA
Send response to journal:
|
It sounds tempting to believe that patient participation would enhance the yield of spontaneous adverse drug reaction monitoring but the experience has been otherwise1. The reasons are many yet lack of patient awareness is the foremost. Now, in country like India where most of the healthcare (75%) is in private hands; most patients get treated by the pharmacists and chemists instead of qualified medical doctors. This is because they believe doctors charge exorbitant fees. For example, in Indian Capital of Delhi, there are only 10,000 registered medical doctors but over 35,000 "official quacks". Unofficial sources put the number of quacks as 100,000. Same is the number of chemists who “treat” patients on daily basis. Now, one private doctor may see 10-20 patient everyday; but one chemist "prescribes" medications to over 200 patients. After adjusting the population of each city if we extended it to the 1 billion Indian population; this can have enormous health implications. No wonder, one chemist remarked, "we are more experienced than doctors". The moot point is patients are not educated enough to know who’s a doctor and who’s not. Then it’s impractical to assume that they would start reporting adverse drug reactions. Now, if such is the case, how could one assume that incorporation of patients would increase the response rate? If patients do not take advice from medical doctors as often they seek helps of paramedical people; it’s virtually impossible to solicit their cooperation in any such endeavor. But that doesn’t mean it happens so, in UK also. I assume, lack of patient awareness or sufficient encouragement for reporting should be a common denominator wherever this scheme is implemented. Now, where have we gone wrong in expecting that the yield would increase by extending the scope of spontaneous adverse drug reaction monitoring to patients and general public is; we are expecting but not teaching! Now, unless someone knows the implications; how would he\she participate? In certain situations even doctors are found to be wary in monitoring; how can patients come up so straightforwardly? Does that mean the scheme is flawed? Not at all; patient participation would be the final yet most essential step in increasing the reporting. The bitter fact that even those countries that envisaged the ADR monitoring do not have spontaneous report rate of over 2% makes it all the more important2. Unless patients are made aware of the implications of sending a report; system would function sub optimally. References 1. William K. Patients will be able to report drugs' side effects. BMJ 2004; 328: 1095-b-0-b. 2. Dhikav V. Adverse drug reaction monitoring in India. J Ind Acad Clin Medicine 2004; 5 (1): 27-33. Competing interests: None declared |
|||
|
|
|||
|
Dr. Naseem A. Qureshi, MD, IMAPA, LMIPS, Medical Director [A], Director, CME&R Buraidah Mental Health Hospital, Postcode.2292, Saudi Arabia
Send response to journal:
|
Dear sir: Previously, only doctors, dentists, coroners, nursing staff and pharmacists were reporting side effects of drugs directly to relevant health authorities in England and Wales. According to this "NEWS ROUNDUP" by Keren (2004), now patients will be able to report the side effects of drugs to similar authorities, which has been accepted by most concerned governmental organizations. Thus, Yellow Card Scheme will be in place and its usefullness though widely acclaimed, some have cast little doubt about the reliability of drugs side effects reported by patients. I raise one moot point, which is " when doctors, dentists, coroners, nurses and pharmacists develop a disease and as a result use prescribed medications and consequently if they develop some side effects, are they n't allowed to report the side effects of drugs because now they are patients?" This will be ridiculous, of course. Hence, medical staff and patients are complementary to each other in advancing many aspects of medical sciences including reporting of drugs side effects. Those who take drugs and develop side effects, they are the best and the finest reporters of drugs side effects. Reference: Keren Williams. Patients will be able to report drugs' side effects. BMJ 2004; 328: 1095-b-0-b Competing interests: Supporter of patients rights |
|||
|
|
|||
|
Nicholas D Moore, Professor of clinical pharmacology Université Victor Segalen, 33076 Bordeaux
Send response to journal:
|
This comment, interesting and refreshing though it is, unfortunately continues to spread a common misconception about the role of spontaneous reporting, showing in fact a total absence of knowledge or thinking about these systems. Spontaneous reporting is designed to identify unusual or rare cases of adverse drug reactions that have not been previously discovered during drug development or clinical trials. It is by nature incapable of estimating the true population and public health consequences of such adverse reactions. To assess the impact of the known adverse drug reactions, there are other means, commmonly called pharmacoepidemiology, that involve systematic study and quantification of the adverse reactions. This is indeed the more modern and current way of working: once an alert has been identified, whether because a drug reaction has been identified before marketing, or through spontaneous reporting (the yellow card) then these pharmacoepi studies are put in place to measure the exact impact of the reaction. Once they have this information, health authorities can then consider the benefit- risk ratio and take the appropriate measures to preserve the public health, taking into account the public's best interest, and usually in a quite transparent manner. For instance all decisions at the european level (more and more common) result in a public disclosure of the reasons behind the decision. Nothing is perfect, and there is still much progress to make, but much has been done in the past years to improve the scientific assessment of adverse drug reactions, understand their mechanisms, in way that have perhaps not been publicized enough. In general drugs are infinitely safer now than they used to be. As far as I know, spontaneous reporting has not missed an important public health signal in the past 40 years or so, expecially with international cooperation (apart from some type C effects which simply cannot be detected by spontaneous reporting). Again, spontaneous reporting is but one of an arsenal of methods. Asking spontaneous reporting to measure the exact impact of adverse reactions on health care is like taking a 30-ton lorry and expecting it to win a grand prix race, then screaming scandal because it doesn't. On the other hand, if you want to transport a piano, a formula 1 car won't be much use. Competing interests: Working in the field for the last 20 years, and quite attached to it |
|||
|
|
|||
|
John Madura, n/a 08859
Send response to journal:
|
I can only speak from my personal experiences as a patient BUT in every single case where I contacted a drug company with either questions or a report of "concerns", their responses were positive. Followup calls and or letters ,from the companies to me, allowed for all concerned to learn and in most cases they offered to interface with my physician. John M NJ USA Competing interests: None declared |
|||
|
|
|||
|
Claire E Jackson-Prior, Full time mother Sutton, Surrey
Send response to journal:
|
I have recently discovered the Yellow Card system for reporting suspected side effects of medicines. I found out about it from a poster in a hospital pharmacy. When I later discovered that I could have been suffering from a side effect of a medicine for many years, I remembered the poster and reported it online. As a patient, not in any way medically trained, I can't see anything but good that could come of the scheme if only the public knew about it. Even the health professionals I have spoken to on the matter have been under the impression that the scheme is just for reporting new side effects. The MHRA asks for any side effect to be reported, even if it is included on the Patient Information Leaflet. Personally I believe that if people knew that they could report their experience of side effects directly to the MHRA, then the would be less inclination for people to feel the need to alert the media about their experiences and cause health scares. Another bonus that I can see, is that people are asked to tell Yellow Card what other medicines they were taking at the same time as the one they suspect. This data could provide an insight into what the public are putting in their mouths behind closed doors and whether they are reading warnings on packets or in PILs. This could lead to new publicity campaigns about how to use medicines, or lead to some Over the Counter medicines being more restricted. I can't help but feel that this, in time, could improve public health and thus save money for the NHS. As I have already said, I a not medically trained. However I really think that Yellow Card could be so useful if the public used it. I don't know if they will choose to do so, but I know they won't if they don't know they can. Competing interests: None declared |
|||