Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Conspiracy against the Laity
- Nadaraja Bathirunathan (7 November 2005)
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Folly and naivety
- James Penston (11 November 2005)
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Patients need unbiased information
- Douglas E Ball (11 November 2005)
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Accessible and patient centred?
- David A Evans (16 November 2005)
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Information for patients on medicines, 5 November
- Richard Barker (21 November 2005)
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Information for patients on Medicines: A reply
- J A Delaney (30 November 2005)
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Nadaraja Bathirunathan, Visiting Professor Dept. Transfusion Medicine,MGR Medical University, Guindy, Chennai, India
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Every profession is a conspiracy against the laity. Doctor's Dilemma, Bernard Shaw. From a young age I was trained not to ask questions. At least four people held me down as the nauseating physic of the Vederala was slammed down my throat. Later when I grew up I knew that nobody knew why they did it or what they got out of it. Only it was a respected profession. That is, the Vederala made his living out of it.If you ask questions the medicine wont work. Later I became a pharmacist. In those days the Doctor scribbled his prescription in Latin. We were strictly warned not to tell the patient anything about the prescribed medicines except how to take them. I think it was in the 1960s the Pharmacetical Society decided that the name of the Drug should be written on the label and I remember the vehement opposition to the decision even by some Pharmacists. I cannot overemphasise the need for telling the patient the name and nature of the drug she(or he) is prescribed and as much information as she needs, wants and can understand. Medical progress depends to a large extent from the response of the patient ; the more intelligent and understanding patient provides better information. Apart from this we know there are criminals in every profession. How can the patient know he got the right medicine? I have always held that it is injustice to deny vital knowledge of importance to anybody. People in authority should be prepared to provide information and answer to questions whether it is about a drug or weapons of mass destruction. There cannot be any doubt that very comprehensive patient centred information should be provided and full information about a drug should be available to anybody who requires it. This is important for the safety of the patients and progress in scientific medicine. The Medical Services exist for the welfare of the patients. Competing interests: None declared |
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James Penston, Consultant Physician/Gastroenterologist Scunthorpe General Hospital, Cliff Gardens, Scunthorpe, North Lincolnshire DN15 7BH
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Sir, Shaw et al. argue that the pharmaceutical industry should be encouraged to play a more substantial role in the provision of information relating to drug therapy. [1] Such a proposal can only be greeted with astonishment. The notion that the pharmaceutical industry can be relied upon to provide “factual, unbiased and non-promotional information about the risks and benefits of their medicines” is frankly ridiculous. The authors must surely be aware of instances of disreputable practice involving pharmaceutical companies and the many occasions on which they have been found guilty of making unwarranted claims about their products. They must also have encountered the widespread manipulation of data that is so much a feature of industry-sponsored randomised controlled trials.[2] Yet, despite this, they propose giving carte blanche to the pharmaceutical companies to disseminate their propaganda in the guise of providing information for patients. The pharmaceutical industry already has enormous influence on the research that provides the evidence concerning drug efficacy and safety – for example, the design clinical trials, the choice of investigators, the collection and analysis of data, the interpretation of results and the preparation of manuscripts, and the decision to publish. It also has no shortage of ways of promoting its products including armies of sales representatives, advertisements in medical journals, glossy circulars, medical meetings in hospitals and general practice, and “key opinion- leaders” – usually well-respected academics, handsomely paid to spread the message at sponsored symposia or to ensure a favourable mention in guidelines. There is no reason to believe that pharmaceutical companies need any more assistance with marketing their products.[3] To forget that the raison d’etre of the pharmaceutical companies is to increase their profits is folly. To believe that they can be trusted to deliver sound and impartial advice about their products is naïve. References [1] Shaw JM, Mynors G, Kelham C. Information for patients on medicines. BMJ 2005;331;1034-5. [2] Penston J. Fiction and fantasy in medical research: the large- scale randomised trial. The London Press. London, 2003. [3] House of Commons Committee: The Influence of the pharmaceutical industry. Fourth Report of Session 2004-05. Published 5th April 2005. Competing interests: None declared |
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Douglas E Ball, Associate Professor Faculty of Pharmacy, Kuwait University, PO Box 24923 Safat 13110, Kuwait
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Shaw and colleagues (1) suggest that the way of dealing with the “seriously flawed” model of communication with patients about their medicines is to allow the pharmaceutical industry to have a greater role accompanied by modification of the Association of British Pharmaceutical Industry’s code of conduct. While there may be wider scope for pharmaceutical companies to respond to enquiries from the public, this model is also seriously flawed given the inherent conflict of interest of pharmaceutical companies between profits and patients. There is a danger that this would allow direct-to-consumer advertising through the backdoor, the flaws of which have been highlighted in recent issues of the Journal (2,3). Patients need access to unbiased information, but it should be the responsibility of the government or health authorities, not the companies, to provide it (4). Ideally, the provision of patient oriented medicines information should come from independent bodies and NHSDirect has been one important step in this direction. Strengthening of this service in collaboration with the pharmaceutical services of primary care trusts and the regional medicines information centres is preferable to extending the influence of pharmaceutical companies. If independent patient medicines information activities need to be expanded, perhaps funding could be provided for by a levy as a percentage of each pharmaceutical company’s spending on advertising. References 1. Shaw JM, Mynors G, Kelham C. Information for patients on medicines. BMJ 2005;331:1034-1035. doi:10.1136/bmj.331.7524.1034 2. Mansfield PR, Mintzes B, Richards D, Toop L. Direct to consumer advertising. BMJ 2005;330:5-6. doi:10.1136/bmj.330.7481.5 3. Lenzer J. Professors speak out against advertising directly to consumers. BMJ 2005;331:1040. doi:10.1136/bmj.331.7524.1040-b 4. Quick JD, Hogerzheil HV, Rago L, Reggi V, de Joncheere K. Ensuring ethical drug promotion—whose responsibility? Lancet 2003;362: 427. Competing interests: None declared |
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David A Evans, General Practitioner Health Centre, High Street, Dronfield. S18 1PY
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I had to do a double take at the sub-title of this article. I visited the medguides website hopeful that, at last, I could direct my patients to a site that explained their medication in simple language and the reasoning behind their use. I was very disappointed. Accessible? First of all, you are faced with an exhaustive list of the preparations of each drug. Why is this? When I look up, for example, atrovent, I am not interested in worrying about whether or not different preparations have different effects - which they do not - I just want to know about atrovent! Patient-Centred? There is no need to regurgitate indications, cautions, contra-indications, side effects and interactions (accessed through fiddly individual submenus). This information is available easily elsewhere, either on-line, in product information leaflets or from the local library's BNF. Reams of information with little or no interpretation is of little help to patients who need assistance in making sense of the Patient Information Leaflet provided with medications. A long list of side effects will only have them visiting their GP saying "I read the list of side effects and I don't want to take it in case I get...". Patients need to know the benefits of the medication and why they are prescribed it despite the possible side-effects or interactions. I will not be directing my patients to a site that provides them with the same information as a BNF. Perhaps the eBNF could be made available to the public. Competing interests: None declared |
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Richard Barker, Director General The Association of the British Pharmaceutical Industry
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The role of the pharmaceutical industry in providing information about medicines to the public may well have been hampered in the past, not so much by what the ABPI Code of Practice forbade as by what companies thought it might forbid (Information for patients on medicines, 5 November). While the restrictions on advertising, marketing or promoting prescription-only medicines to the public, imposed by legislation as well as the code, remain very much in force, the revised ABPI code addresses in more detail the provision of information to the public. The revised code was the subject of consultation with the Medicines and Healthcare products Regulatory Agency as well as the British Medical Association, Royal Pharmaceutical Society of Great Britain and Royal College of Nursing. Anybody concerned about information to the public or advertising to health professionals may submit a complaint to the Prescription Medicines Code of Practice Authority. The new code is similar to the current code in that information must be factual, presented in a balanced way and must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product. Statements must not be made for the purpose of encouraging the public to ask their health professional to prescribe a specific prescription only medicine (Clause 20.2). However, the new supplementary information to Clause 20.2 sets out in much more detail than currently the type of information that can be provided by the industry. For example, the concept of reference information as a comprehensive, up-to-date resource for the public relating to prescription only medicines with marketing authorisations has been introduced. Reference information includes the regulatory information (summaries of product characteristics, package leaflets and public assessment reports where available) as well as registration studies, other studies, medicine guides information about diseases and about specific medicines. Reference information must represent fairly the current body of evidence relating to a medicine and its benefit/risk profile. Companies are not obliged to provide reference information but are advised that it is good practice to provide at least the regulatory information as a minimum. As a consequence of consultation with stakeholders as part of the review process, a guide to the code for the public will be produced. The industry has also been an active partner in the Ask About Medicines range of activities, which centred on the Ask About Medicines Week in November. The industry has long been campaigning for more freedom to communicate non-promotional information to the public, beyond what is currently permitted under UK law or the ABPI code, and this will continue. The article by Joanne Shaw et al is absolutely right to highlight the benefits that will result if the pharmaceutical industry is enabled to communicate better with those who are its ultimate customers – patients. Competing interests: None declared |
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J A Delaney, Statistician Clinical Epidemiology, Royal Victoria Hospital, Montreal, QC, Canada, R 4.36, 687 Pine Ave W,H3A1A1
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I read with great interest the article by Shaw, Mynors and Kelham about the need to improve the information that patients have on medications (1). It is important to give patients proper information on the potential side effects of medication. The authors of the article propose an industry-government partnership in the form of a multi-sector board to inform patients of medication risk. However, as the case of Vioxx in the United States shows, it is possible for both industry and regulatory agencies to fail in the presence of a serious side effect (2). Proper surveillance of pharmaceutical products requires more than just the clinical trial information used to license the drug as such studies may be underpowered to detect rare side effects (3). In addition, there have been problems recently with the reporting of clinical trials (4) which make relying on these as the sole source of information on drug side effects very worrying. Therefore, I would like to propose that there be a addition to any such effort; that of pharmacoepidemiology studies in administrative databases. These studies can be carried out in a variety of databases, like Britain’s General Practice Research Database (5), and can provide additional evidence of drug side effects and ensure that patients are properly informed of potential risks. In particular, they decrease the possibility of errors of omission where a key side effect, like that of Vioxx which increased the risk of myocardial infarction, is not discovered until after the drug has been released to the market.. It’s true that this would require careful communication in order to account for different weights of evidence when informing patients. But it seems better to err on the side of making too much information available to patients than too little given the potential consequences of mistakes about drug safety. JA Delaney, MA
1. Shaw JM, Mynors G, Kelham C. Information for patients on medicines. BMJ 2005;331:1034-5. (5 November.) 2. Topol EJ. Failing the public health—rofecoxib, Merck, and the FDA. N Engl J Med 2004;351:1707-9. 3. Layton D, Key C, Shakir SA. Prolongation of the QT interval and cardiac arrhythmias associated with cisapride: limitations of the pharmacoepidemiological studies conducted and proposals for the future. Pharmacoepidemiol Drug Saf 2003;12(1):31-40. 4. Dyer O. GlaxoSmithKline faces US lawsuit over concealment of trial results. BMJ 2004;328:1395. 5. Wood L, Martinez C. The general practice research database: role in pharmacovigilance. Drug Saf 2004;27:871-81. Competing interests: None declared |
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