Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Conflicts of interest should be disclosed
- Andrzej Gorski (5 July 2002)
-
How should payments to the investigator be disclosed ?
- Howard Mann (5 July 2002)
-
Ethics of clinical trials
- Frank O Wells (5 July 2002)
-
Misleading Supposition
- Guy P. Johnson (6 July 2002)
-
Undisclosed payments in research
- Jacqueline M Atkinson (8 July 2002)
-
Research in the real world
- Peter G Hutchison (11 July 2002)
-
Undisclosed payments in research
- Kevin S Channer, Peter J Pugh and Chris J Malkin (11 July 2002)
-
GMC Guidance clear
- Bryan G Vernon (12 July 2002)
-
Disclosure of research payment and mechanism of determination of payment amount are essential
- Tim M Reynolds (27 July 2002)
-
Does disclosure protect the subject?
- John Saunders (15 August 2002)
|
|
|||
|
Andrzej Gorski, Head, Bioethics Commission, Ministry of Health, Poland The Medical University of Warsaw, 02006 Warsaw, Poland
Send response to journal:
|
I fully agree with the authors. During the recent international bioethical conference on conflict of interest http://surfer.iitd.pan.wroc.pl/events/ConferenceApril2002.html Dr Human Delon (Secretary General, WMA)and others expressed similar opinions. Moreover, I believe that elected leaders of academic and scientific community should also disclose such conflicts. Gorski A. JAMA 2001,285,2325. |
|||
|
|
|||
|
Howard Mann, Program Associate, Division of Medical Ethics University of Utah School of Medicine 84132
Send response to journal:
|
Editor -- I commend Rao and Cassia for raising this important issue again. My own view on this matter accords with sentiments expressed by Marcia Angell, former editor of the New England Journal of Medicine, who called for the elimination -- rather than the management -- of financial conflicts of interest as far as possible.[1] Disclosure is, however, a necessary requirement that should be adopted by research ethics committees. How should this be accomplished in the consent document potential participants are requested to read and sign? La Puma and Kraut have suggested an institutional policy in this regard.[2] In their article, they quote Roizen [3] who suggested the following form of disclosure for capitation payments: "The investigator will be compensated X dollars by X company for each person enrolled as a subject in this study. The investigator's own direct cost is X for each person enrolled. The investigator plans to use the funds for X. Please feel free to ask about the compensation the investigator is receiving for performing this research." Howard Mann, M.D. Competing interests : None declared. [1] Remarks of Marcia Angell,M.D. Delivered at the HHS Conference on Financial Conflicts of Interest 8/16/00. Available at: http://ohrp.osophs.dhhs.gov/coi/angell.htm [2] La Puma J, Kraut J. "How much do you get paid if I volunteer?" Suggested institutional policy on reward, consent, and research. Hospital & Health Services Administration. 1994; 39:193-203. [3]Roizen R. Why I oppose drug company payment of physician/investigators on a per patient/subject basis. IRB 1988; 10(1);9-10. |
|||
|
|
|||
|
Frank O Wells, Non-executive Chairman, Chairman, Marix Drug Development Ltd Marix, Cathedral Road, Cardiff, CF11 9UY
Send response to journal:
|
I write as a member and former chairman of the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine, former Medical Director of the ABPI, and a member of two research ethics committees. Rao and Cassia make a number of points which quite disregard the truth about phase IV clinical trials and which fail to differentiate between phase IV clinical trials and the safety assessment of marketed medicines (SAMM), both of which are subject to strict guidelines. These should be familar to members of research ethics committees but which are clearly unfamiliar to the authors of this paper. Phase IV clinical trials, soon to be covered by the national legislation which follows the adoption of the EU Directive on Clinical Trials, are scientific projects, aleady subject to ethical review. They are done in accordance with protocols which are submitted to MRECs and LRECs as appropriate, and payments to be made are clearly included in the application for ethical review. Neither they, nor SAMM studies, are designed solely "to familiarise doctors with new and recently licensed medicines". Indeed, they may well be required by the licensing authority to be conducted to establish a more robust safety database for the new medicines in question. What I find saddest about the Rao and Cassia paper is their seeming ignorance of what they can already do about the concerns they express. Only this week, at the BMA Annual Meeting, the need for the suggested fee for involvement in clinical research to be widely published was endorsed, just so that research ethics committees, amongst others, can have up-to- date independent advice on what is an agreed benchmark for payment to doctors taking part in such studies. Every phase IV study sponsored by a pharmaceutical company must be submitted to the appropriate research ethics committee(s) which can turn down an application if it is felt that the payment is coercive. SAMM studies do not need research ethics committee review, but there is a BMA suggested payment for these, too, and if it is felt by any third party that a study is a marketing exercise masquerading as a research project or a SAMM study, then the company in question can be referred to the Prescription Medicine Code of Practice Authority as a complaint, and sanctions against the company can follow if the complaint is upheld. In conclusion, I would totally agree that "undisclosed payments to doctors recruiting patients in clinical trials" would be unethical. However, it is already a requirement that payments are disclosed to research ethics committees, and it is therefore up to the RECs to ensure that such disclosure occurs, and that what is disclosed is acceptable. Dr Frank Wells |
|||
|
|
|||
|
Guy P. Johnson, Faculty, George Washington University's Clinical Research Administration Program 6559 Memphis Street, New Orleans, LA 70124 USA
Send response to journal:
|
The authors frame their ethical dilemma in a very misleading way: "Doctors are often paid to recruit patients to clinical trials sponsored by pharmaceutical companies." I would propose that the authors re-phrase this statement as follows: "Doctors are often paid to conduct clinical trials sponsored by pharmaceutical companies." My research experience is as a business manager who negotiated hundreds of clinical research budgets for Phase I-III studies conducted in America. In these types of studies, the physician is paid not only to recruit study subjects but to conduct the research study. In a typical phase III study in the US, the conduct of the clinical trial means that the study subject will be seen in clinic 10 to 15 times over a period of 3 to 6 months. These clinic visits will require a full battery of medical procedures and laboratory work, each of which needs to be documented in an ever-expanding and detailed paper trail. And this paper record will be examined (and audited) by representatives of the sponsor and by regulatory agencies for many years following the conclusion of the research study by the individual investigator. To compare a research physician to an insurance salesperson is materially misleading. An insurance salesperson's job essentially is over the minute a person buys the insurance policy. A research physician's job is just beginning the minute s/he recruits a patient into a clinical trial. If the authors were to compare a research physian's job to that of a salesperson, I would propose that the authors describe the research physician to that of an automobile salesperson. Of course, I'd also add that to be truly comparative to the research physician, the automobile salesperson would have to sell the auto to the buy -- and then go to the factory to build the automobile! Guy P. Johnson, CPA, MS Faculty, The George Washington University's Clinical Research Administration Program |
|||
|
|
|||
|
Jacqueline M Atkinson, senior lecturer Dept Public Health, University of Glasgow I Lilybank gdns Glasgow G12 8RZ
Send response to journal:
|
Sir For many years now The Greater Glasgow Community/Primary Care Local Research Ethics Committee has insisted that reference to docotors' payment is part of the patient information sheet that goes to all potential participants. Furthermore, we object to the payment being hidden behind such phrases as 'your doctor's research fund will be paid', which a number of MRECs allow. We note, however, that the phrase 'for the additional work involved' often appears. Despite the NHS and NHSScotland being the remit of two different Parliaments cross border acceptance of approval by MRECs exists. It is also likely that patients see the NHS as a whole and the ethical principles of doctors and other health care professionals not having regional variations. In the interests of equality (as well as informed consent) it would seem appropriate for UK guidelines to be developed on this and other minimum requirements of information to be given to patients. This could include the amount of payment. A quick, non-random survey (i.e. my non-medical family and friends) suggests that the amount of the payment and the potential overall income is underestimated. There are other types of personal gain for researchers which I also believe potential parcipants should know about - when the work forms part of the requirements for a degree. Some people who already have a professional qualification and who are using 'their' patients in research do not always believe it is necessary to inform patients that they are registered for a degree for which this research is necessary. This research may not always reach publication and may be designed as a learning experience rather than a complete piece of research. If patients are to be expected to take part in research for altruistic reasons they have a right to know what reasons motivate those carrying out the research. Yours faithfully
|
|||
|
|
|||
|
Peter G Hutchison, General Practitioner Greyfriars Medical Centre, Dumfries DG1 1DL
Send response to journal:
|
Ethics of undisclosed payments to doctors recruiting patients in
clinical trials
I totally support the proposal in Rao and Sant Cassa's article (1) that any payments must be openly declared by research workers. Honesty and openness make for peace of mind, clarity and genuinely informed consent. I also wholeheartedly endorse the condemnation of per capita payments for recruiting patients. No such studies should ever receive ethical approval, especially if of dubious value such as post marketing observational studies. Payment for a researcher's time, however, is different. We must recognise what is a realistic hourly rate for research work. The pejorative statement that "well organised British general practices can earn an extra £15000 annually for three hours' work a week" is naïvely critical. This sum is actually less than I would have expected given that a GP has to run a business as well as do research. The BMA recommended fee for clinical trial work (2) is in fact currently £158.50 per hour equating to £24726 for this commitment (rather over the top in my view, but it puts £15000 in perspective). In contrast to hospital staff, when a GP is not available for his NHS work, he has to personally employ a locum. He also has to pay for the running of his business, including staff salaries and premises; it is not all reimbursed by the NHS. If a hospital doctor had the same financial responsibility to pay for the infrastructure of a hospital department, I hate to think what hourly rate the BMA would recommend. British general practice is currently suffering a crisis of demand exceeding resources. Workload is such that few have the chance to find time to enjoy the "buzz of research", no matter how enthusiastic they might be. It is unrealistic to expect that research should always be done as an unpaid extra in a doctor's scant and precious free time. Sadly we now have to live in the world of painful commercial reality. Yours sincerely Dr Peter Hutchison, References 1. Ethics of undisclosed payments to doctors recruiting patients in clinical trials, Jammi N Rao, L J Sant Cassa, BMJ 2002;325:36-37 2. http://www.bma.org.uk/ap.nsf/Content/EXT-Fees (10/07/02) |
|||
|
|
|||
|
Kevin S Channer, Consultant Physician and Cardiologist Department of Cardiology, Royal Hallamshire Hospital, Sheffield S10 2JF, Peter J Pugh and Chris J Malkin
Send response to journal:
|
Dear Editor, As busy hospital clinicians who regularly recruit patients into commercial trials, we were alarmed to read the article by Rao and Cassia concerning "undisclosed payments to doctors."1 Either they have got their facts wrong or we have been hoodwinked by numerous companies, which owe us thousands of pounds! We suspect the former is, sadly, the case. The clear implication on reading the article is that companies pay doctors for recruiting patients into trials "in addition to the doctor's regular income." This is simply untrue. Over the past 13 years, during participation in dozens of commercially funded trials, no doctor in this department has received any remuneration for recruiting patients. Our department receives income to compensate for the time medical and nursing staff spend on this work and we employ two research nurses and two clinical fellows who also do their own research leading to higher degrees. The company pays for all consumables involved and the Trust charges a 30% levy for overhead costs. We believe that patients would be disturbed to think that NHS facilities were being used by pharmaceutical companies without recompense. We have a symbiotic relationship with industry which allows us to contribute to the development of new treatments for patients and provides an income stream to underpin our personal research endeavours assisted by financial support from major charities. It is wrong to think that patients do not benefit from taking part in commercially-sponsored clinical trials. They are more likely to receive specialist care, closer follow up and appropriate evidence-based treatment than non-trial patients.2 Participation has been associated with markedly improved survival, not completely explained by the trial therapy, even after adjusting for population differences.3 In addition, over 75% of participants in trials for heart failure report subjective improvement, irrespective of the outcome of the trial.4 So, should doctors disclose "pecuniary interests" to patients when inviting them to participate in clinical trials? Yes, of course, but the only disclosure to make is that the staff involved in the trial are salaried, just like everyone else. It may be different in general practice where doctors are self- employed individuals, but to imply that doctors involved in research are currently not disclosing financial incentives to their patients is incorrect, even slanderous, and serves only to create distrust between doctors and patients. Such trust is precious and highly valued on both sides of the relationship. Care must be taken both by authors and by editors of prominent journals like the BMJ not to erode it by publishing misinformation in an unbalanced way. Yours sincerely, Dr Peter J Pugh, MRCP(UK) Dr Chris J Malkin, MRCP(UK) Dr Kevin S Channer, MD FRCP References 1. Rao JN, Cassia LJ. Ethics of undisclosed payments to doctors recruiting patients in clinical trials. Br Med J 2002;325:36-37. 2. Brown N, Melville M, Gray D, Young T, Skene AM, Wilcox RG, Hampton JR. Relevance of clinical trial results in myocardial infarction to medical practice: comparison of four year outcome in participants of a thrombolytic trial, patients receiving routine thrombolysis, and those deemed ineligible for thrombolysis. Heart 1999;81:598-602. 3. Jha P, Deboer D, Sykora K, Naylor CD. Characteristics and mortality outcomes of thrombolysis trial participants and nonparticipants: a population-based comparison. J Am Coll Cardiol 1996;27:1335-1342. 4. Yuval R, Uziel K, Gordon N, Merdler A, Khader N, Karkabi B, Flugelman MY, Halon DA, Lewis BS. Perceived benefit after participating in positive or negative / neutral heart failure trials: the patients' perspective. European Journal of Heart Failure 2001;3:217-223. |
|||
|
|
|||
|
Bryan G Vernon, Lecturer in Health Care Ethics Newcastle Medical School, NE2 4HH, UK
Send response to journal:
|
The General Medical Council's advice to researchers is clear. In Paragraph 14 of its guidance on Research: the Roles and Responsibilities of Doctors, published in February this year, it states, "You must be open and honest in all financial matters relating to your research and its funding. In particular you must…give participants information on how the research is funded, including any benefits which will accrue to the researchers and/or their departments." Rao and Cassia have more support for their position than they imagine! The web address is http://www.gmc- uk.org/standards/standards_frameset.htm |
|||
|
|
|||
|
Tim M Reynolds, Consultant Chemical Pathologist and Chairman South Staffordshire LREC Queen's Hospital, Burton-on-Trent, DE13 0RB
Send response to journal:
|
Rao & Salt Cassia [1] are indeed correct when they state that phase IV clinical trials are frequently thinly disguised marketing and that payments should be disclosed to patients when they are recruited. Ethics committees frequently comment on the apparent marketing functions of some trials but approve them nevertheless because there is some science included in the protocol. Payment for participation in trials is also recognised to be essential to persuade clinicians to spend extra time in order to recruit and monitor patients according to trial protocols and to pay for ancillary staff when these are used. Often however, the value of the payment does not appear to correlate with the amount of input required; i.e. frequently more simple trials often pay more than complex trials requiring multiple visits and in these cases ethics committees may be particularly uneasy. Discussion of this issue is made more difficult by the duty of Confidentiality imposed on ethics committees. Sadly they do not go far enough in the recommendations for disclosure. Not only should the fact and size of payment be disclosed to payments but also the eventual destination of the money. When I recruit patients to trials I always inform them exactly how much I will be paid for their participation and that the money will go to departmental funds for purchase of equipment, staff training and other research; and more specifically that none of the money will ever arrive in my wallet to pay for my summer holidays. Once patients know that direct personal gain is not the motive for carrying out trials they are generally pleased to participate. Difficulties may arise however outside of the hospital sector such as in general or private practice where independent contractor status means that drug trial profits may appear to flow to the recruiter, either directly or indirectly by covering practice expenses that leaves a larger sum to be distributed as ‘profit’. The regulatory framework needs to be strengthened to take into account the above concerns with a requirement for an itemised breakdown of the time required to complete the study documentation etc, and an hourly rate so that trials that are clearly over-paying as a form of marketing can be identified more easily. REFERENCES 1. Rao JN, Cassia LJ. Ethics of undisclosed payments to doctors recruiting patients in clinical trials. Br Med J 2002;325:36-37. |
|||
|
|
|||
|
John Saunders, consultant physician Nevill Hall Hospital, Abergavenny, NP7 7AG
Send response to journal:
|
Rao & Cassia provide a welcome contribution to a thorny issue. Given that money is the most reliable motivating factor for most of our daily activities, and that motivation is at least part of ethical analysis, it does seem odd that the subject has been so little discussed. We do, after all, know that it has been an incentive to research fraud in some high profile cases. Yes, disclosure must be the right principle when one party is receiving major financial incentives, (either indirectly to a department or even personally via the practice income), especially when the other party takes the risk and does it for no payment. But does disclosure protect the subject? If a department benefits in purchase of equipment or employment of staff, there may be a powerful incentive to participate against one's better judgement. To learn that the cash goes to the researcher's own income might produce the opposite response. Is it moral to take excessive payment for the benefit of the hospital but immoral if most is for the investigator's personal gain? Either way, one has to justify excess. At least part of the problem is the high level of payment. Overheads are often paid separately or part of pre-existing facilities. At the BMA 'benchmark' of £158 per hour, the rate is simply too high. (Work out how much a doctor with a 40 hour week in a 46 week year earns per hour if paid £70000 per annum by way of comparison). And those rates are often paid for functions not carried out by doctors at all. Why pay that rate for the practice nurse to do simple functions? Ethics committees are not consistent in their examination of payments and the assertion in the application form that "BMA guidelines will be followed" should be checked. My experience is that it often isn't the basis for the financial calculation. Better and more uniform guidance is required including rates for non-medical work. But £158 per hour is too high and I think a lot of patients will not be impressed if that's mostly going into someone's pocket. |
|||