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PubMed1975

Patients' rights.

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Ethics Committees↗
PubMed2004

Recommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis.

BACKGROUND: Recent innovations in the pharmaceutical drug discovery environment have generated new chemical entities with the potential to become disease modifying drugs for osteoarthritis (DMOAD's). Regulatory agencies acknowledge that such compounds may be granted a DMOAD indication, providing they demonstrate that they can slow down disease progression; progression would be calibrated by a surrogate for structural change, by measuring joint space narrowing (JSN) on plain X-rays with the caveat that this delayed JSN translate into a clinical benefit for the patient. Recently, new technology has been developed to detect a structural change of the OA joint earlier than conventional X-rays. OBJECTIVE: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working party to assess whether these new technologies may be used as surrogates to plain x-rays for assessment of DMOADs. METHODS: GREES includes academic scientists, members of regulatory authorities and representatives from the pharmaceutical industry. After an extensive search of the international literature, from 1980 to 2002, two experts meetings were organized to prepare a resource document for regulatory authorities. This document includes recommendations for a possible update of guidelines for the registration of new chemical entities in osteoarthritis. RESULTS: Magnetic resonance imaging (MRI) is now used to measure parameters of cartilage morphology and integrity in OA patients. While some data are encouraging, correlation between short-term changes in cartilage structure observed with MRI and long-term radiographic or clinical changes are needed. Hence, the GREES suggests that MRI maybe used as an outcome in phase II studies, but that further data is needed before accepting MRI as a primary end-point in phase III clinical trials. Biochemical markers of bone and cartilage remodelling are being tested to predict OA and measure disease progression. Recently published data are promising but validation as surrogate end-points for OA disease progression requires additional study. The GREES suggests that biochemical markers remain limited to 'proof of concept' studies or as secondary end-points in phase II and III clinical trials. However, the GREES emphasizes the importance of acquiring additional information on biochemical markers in order to help better understand the mode of action of drugs to be used in OA. Regulatory agencies consider that evidence of improvement in clinical outcomes is critical for approval of DMOAD. Time to total joint replacement surgery is probably the most relevant clinical end-point for the evaluation of efficacy of a DMOAD. However, at this time, time to surgery can not be used in clinical trials because of bias by non disease-related factors like patient willingness for surgery or economic factors. At this stage, it appears that DMOAD should demonstrate a significant difference compared to placebo. Benefit should be measured by 3 co-primary end-points: JSN, pain and function. Secondary end-points should include the percentage of patients who are 'responder' (or 'failure'). The definition of a 'failure' patient would be someone with progression of JSN>0.5mm over a period of 2-3 years or who has a significant worsening in pain and/or function, based on validated cut-off values. The definition of the clinically relevant cut-off points for pain and function must be based on data evaluating the natural history of the disease (epidemiological cohorts or placebo groups from long-term studies). These cut-offs points should reflect a high propensity, for an individual patient, to later require joint replacement. CONCLUSION: GREES has outlined a set of guidelines for the development of a DMOAD for OA. Although these guidelines are subject to change as new information becomes available, the information above is based on the present knowledge in the field with the addition of expert opinion.

Anthraquinones↗
PubMed2002

From Lydia Pinkham to Bob Dole: what the changing face of direct-to-consumer drug advertising reveals about the professionalism of medicine.

From its founding in 1847, the AMA divided drugs into "ethical" and "unethical" preparations. Those that were ethical had a known composition and were advertised only to the profession. Other, patent medicines (technically proprietary drugs, whose trademarks were protected by copyright), were sold directly to the public. In spite of the AMA's efforts to ban the advertising and sale of those nostrums, proprietary drugs flourished during the nineteenth century. Starting in 1900, however, three major societal trends combined to bolster the AMA's campaign, and by 1920 almost all advertising was directed to physicians, who would then prescribe medications to their patients. This ban on advertising pharmaceuticals directly to the public remained virtually unchanged until approximately 1980. Since then, it has slowly eroded and, as recently as 1997, the FDA created guidelines for pharmaceutical companies to advertise on television. What does this change say about the profession of medicine, the role of the physician in society, and the doctor-patient relationship? Using a comparative historical approach, this paper examines these issues.

Advertising↗
PubMed1993

Publishing the findings of clinical research.

Current regulations and practice may not prevent a sponsor of clinical research from delaying or preventing the dissemination of findings that do not support his or her commercial, professional, or managerial interests. Pharmaceutical trials are particularly subject to this concern, but the issue of non-publication has a wider significance. Patients participate in research on the understanding that it will be of public benefit. To be fair to these patients we must confirm that data will be analysed without bias and that findings will be regarded as being in the public domain and hence available to interested reviewers even if the results do not justify publication. Clinical investigators and ethics committees have the power and the duty to enforce this outcome.

Biomedical Research↗
PubMedDate not supplied

The business of ethics. Hospitals need to focus on managerial ethics as much as clinical ethics.

Business ethics begins with the recognition of the various values and "goods" involved in judgements of what to do. Four key values are individual rights, individual self-interest, the company's best interest, and the public good. Often a company has to choose which of these goals or values should be subordinated to another. Business ethics, then, must clarify priorities among these values and establish priority principles to resolve conflicts. One approach to contemporary business ethics emphasizes personal integrity, focusing on conflicts of interest; another approach stresses social responsibility, focusing on the effect of company policy on groups and individuals in society. In business, most of the attention to conflicts of interest focuses on the conflict between employee self-interest and the firm's interest. Healthcare organizations may need to focus on potential conflicts between the patient's interest and the institution's or physician's interest. Physician referrals and pharmaceutical companies' marketing practices are two areas with potential conflicts. Not-for-profit organizations have been quicker than the business world to acknowledge social responsibility. In many ways, however, the social impact of healthcare policies and decisions has not been as carefully considered as it should be. Institutionalizing deliberation about clinical ethical issues has helped to raise awareness about the ethical dimensions of medical care. It would also be useful to institutionalize attention to business ethics in healthcare.

Catholicism↗