- Email: [email protected]
Releasing the grip of big pharma
CORRESPONDENCE
COMMENTARY
CORRESPONDENCE e-mail submissions to [email protected]
Releasing the grip of big pharma Sir—In your April 14 editorial1 on the tightening grip of the pharmaceutical industry, you cite instances of pharmaceutical manufacturers requiring the manufacturers’ approval before publication (which they can withhold) and preventing investigators from publishing the full information obtained in a study. This adds to the publication bias, making drugs look better than they really are. To correct this effect, a registry of controlled clinical trials has been established.2 This registry makes the existence of a trial public but does not force publication of the results. A way to force publication is to make promised publication a requirement for ethics committee approval of the study. Patients are recruited into a clinical trial with the understanding that they are participating in medical research. They believe they are contributing to medical knowledge and not just to the commercial interests of the study sponsor. Thus, if the full results of the study are not made publicly available, the study will not contribute to medical knowledge and the participants will have been recruited by fraud. This ethical issue is appropriate for institutional review boards and ethical committees to address in the process of reviewing a study. A requirement for approval should be the promise that the study will be published in full within a reasonable time.3 I suggest submission of the report within 2 years of the last data being collected. There should be penalties for non-adherence with this new part of the informed consent. Because so many institutions and investigators are dependent on the funds from sponsored studies, this requirement cannot be implemented piecemeal. Organisations such as medical-school and teaching-hospital groups must agree to implement this review as a group, so no one institution will be at a competitive disadvantage compared with the others. Currently, the only way to ensure that the results of research in human beings is made public is to require that they be made public. The ethical issue of fulfilling the implied promise that the volunteer will contribute to medical
664
knowledge enables the reviewing committee to make this an enforceable requirement for ethical approval. M M Reidenberg Weill Medical College of Cornell University, 1300 York Avenue, New York, NY 10021, USA 1 2 3
Editorial. The tightening grip of big pharma. Lancet 2001; 357: 1141. Horton R. Medical editors trial amnesty. Lancet 1997; 350: 756. Reidenberg MM. Decreasing publication bias. Clin Pharmacol Ther 1998; 63: 1–3.
Sir—You wonder about the right of drug companies to manipulate studies’ conclusions, and about the effect of unpublished industry-funded research.1 The Commissione Unica del Farmaco (CUF) of the Italian Ministry of Public Health has promulgated a bill about phase-III drug testing for family physicians and family paediatricians.2 General medicine is also the ideal setting to do observational tests to assess the effect of drugs in terms of their impact on benefits and safety in clinical routine. The CUF document will, 2 years after approval of the final document, entrust the sponsor proposing the research with the task of selecting a coordinator-tester and an ethics committee to supervise the tests. We believe that, in most cases, the pharmaceutical industry will be the proposing sponsor. In coming years, this action could lead not only to the risks you foresee, but also to a greater interest in studies that assess the effects of drugs than in those that study the effects of other types of medical intervention. Di Blasi and colleagues3 and the accompanying commentary of van Weel4 underlined the importance of context studies in general practice, stressing that “with the strong interaction between patient-related circumstances and ‘proven’ therapies being the true stuff of general practice, study of this relation is where clinical research derives its relevance”. We agree entirely with those observations. Our fear is that, in coming years, such experimentation, which focuses on the context rather than only on the effectiveness of a drug, will excite
increasingly less interest company sponsors.
in
drug
*Sergio Conti Nibali, Maria Francesca Siracusano Azienda Sanitaria Locale n5, Via Garibaldi 308, 98123 Messina, Italy (e-mail: [email protected]) 1 2
3
4
Editorial. The tightening grip of big pharma. Lancet 2001; 357: 1141. www.24orebusiness.ilsole24ore.com/sanita/ home_sanita.jhtml (accessed May 17, 2001). Di Blasi Z, Harkness E, Ernst E, Georgiou A, Kleijnen J. Influence of context effects on health outcomes: a systematic review. Lancet 2001; 357: 757–62. van Weel C. Examination of context of medicine. Lancet 2001; 357: 733.
Sir—In your April 14 editorial,1 you draw attention to contract research agreements that contain a clause allowing suppression of publication. You suggest that academic institutions could intervene to support scientists but quite rightly point out that where commercialisation has become a priority to support institutional finances this intervention may not happen. Surely for clinical research this is a matter for ethics committees? Every ethics committee form should contain a clear question “Are you free to publish the results of this study?” Of course, a company would wish to have the opportunity to comment on any proposed publication, or might need to delay it for a specified period of time (eg, not longer than 6 months) to protect commercial interest. However, any complete embargo on publication should be a reason for rejection of the application by the ethics committee. To fail to adopt this approach would mean that volunteers in research would be subject to the inevitable risk of experimentation with the very real possibility that the results of the study would never reach the public domain. Patrick Vallance Centre for Clinical Pharmacology, Rayne Institute, 5 University Street, University College London, London WC1E 6JJ, UK
1
Editorial. The tightening grip of big pharma. Lancet 2001; 357: 1141.
THE LANCET • Vol 358 • August 25, 2001
For personal use. Only reproduce with permission from The Lancet Publishing Group.
COMMENTARY
CORRESPONDENCE e-mail submissions to [email protected]
Releasing the grip of big pharma Sir—In your April 14 editorial1 on the tightening grip of the pharmaceutical industry, you cite instances of pharmaceutical manufacturers requiring the manufacturers’ approval before publication (which they can withhold) and preventing investigators from publishing the full information obtained in a study. This adds to the publication bias, making drugs look better than they really are. To correct this effect, a registry of controlled clinical trials has been established.2 This registry makes the existence of a trial public but does not force publication of the results. A way to force publication is to make promised publication a requirement for ethics committee approval of the study. Patients are recruited into a clinical trial with the understanding that they are participating in medical research. They believe they are contributing to medical knowledge and not just to the commercial interests of the study sponsor. Thus, if the full results of the study are not made publicly available, the study will not contribute to medical knowledge and the participants will have been recruited by fraud. This ethical issue is appropriate for institutional review boards and ethical committees to address in the process of reviewing a study. A requirement for approval should be the promise that the study will be published in full within a reasonable time.3 I suggest submission of the report within 2 years of the last data being collected. There should be penalties for non-adherence with this new part of the informed consent. Because so many institutions and investigators are dependent on the funds from sponsored studies, this requirement cannot be implemented piecemeal. Organisations such as medical-school and teaching-hospital groups must agree to implement this review as a group, so no one institution will be at a competitive disadvantage compared with the others. Currently, the only way to ensure that the results of research in human beings is made public is to require that they be made public. The ethical issue of fulfilling the implied promise that the volunteer will contribute to medical
664
knowledge enables the reviewing committee to make this an enforceable requirement for ethical approval. M M Reidenberg Weill Medical College of Cornell University, 1300 York Avenue, New York, NY 10021, USA 1 2 3
Editorial. The tightening grip of big pharma. Lancet 2001; 357: 1141. Horton R. Medical editors trial amnesty. Lancet 1997; 350: 756. Reidenberg MM. Decreasing publication bias. Clin Pharmacol Ther 1998; 63: 1–3.
Sir—You wonder about the right of drug companies to manipulate studies’ conclusions, and about the effect of unpublished industry-funded research.1 The Commissione Unica del Farmaco (CUF) of the Italian Ministry of Public Health has promulgated a bill about phase-III drug testing for family physicians and family paediatricians.2 General medicine is also the ideal setting to do observational tests to assess the effect of drugs in terms of their impact on benefits and safety in clinical routine. The CUF document will, 2 years after approval of the final document, entrust the sponsor proposing the research with the task of selecting a coordinator-tester and an ethics committee to supervise the tests. We believe that, in most cases, the pharmaceutical industry will be the proposing sponsor. In coming years, this action could lead not only to the risks you foresee, but also to a greater interest in studies that assess the effects of drugs than in those that study the effects of other types of medical intervention. Di Blasi and colleagues3 and the accompanying commentary of van Weel4 underlined the importance of context studies in general practice, stressing that “with the strong interaction between patient-related circumstances and ‘proven’ therapies being the true stuff of general practice, study of this relation is where clinical research derives its relevance”. We agree entirely with those observations. Our fear is that, in coming years, such experimentation, which focuses on the context rather than only on the effectiveness of a drug, will excite
increasingly less interest company sponsors.
in
drug
*Sergio Conti Nibali, Maria Francesca Siracusano Azienda Sanitaria Locale n5, Via Garibaldi 308, 98123 Messina, Italy (e-mail: [email protected]) 1 2
3
4
Editorial. The tightening grip of big pharma. Lancet 2001; 357: 1141. www.24orebusiness.ilsole24ore.com/sanita/ home_sanita.jhtml (accessed May 17, 2001). Di Blasi Z, Harkness E, Ernst E, Georgiou A, Kleijnen J. Influence of context effects on health outcomes: a systematic review. Lancet 2001; 357: 757–62. van Weel C. Examination of context of medicine. Lancet 2001; 357: 733.
Sir—In your April 14 editorial,1 you draw attention to contract research agreements that contain a clause allowing suppression of publication. You suggest that academic institutions could intervene to support scientists but quite rightly point out that where commercialisation has become a priority to support institutional finances this intervention may not happen. Surely for clinical research this is a matter for ethics committees? Every ethics committee form should contain a clear question “Are you free to publish the results of this study?” Of course, a company would wish to have the opportunity to comment on any proposed publication, or might need to delay it for a specified period of time (eg, not longer than 6 months) to protect commercial interest. However, any complete embargo on publication should be a reason for rejection of the application by the ethics committee. To fail to adopt this approach would mean that volunteers in research would be subject to the inevitable risk of experimentation with the very real possibility that the results of the study would never reach the public domain. Patrick Vallance Centre for Clinical Pharmacology, Rayne Institute, 5 University Street, University College London, London WC1E 6JJ, UK
1
Editorial. The tightening grip of big pharma. Lancet 2001; 357: 1141.
THE LANCET • Vol 358 • August 25, 2001
For personal use. Only reproduce with permission from The Lancet Publishing Group.