Archive for 30 abril 2009

¿Nueva política frente a los conflictos de interés en USA?

abril 30, 2009

La revista New England Journal of Medicine publica un trabajo de Steinbrook sobre este tema (Controlling Conflict of Interest — Proposals from the Institute of Medicine). Steinbrook hace una breve revision del tema y concluye haciendo una enumeración de las sugerencias del IOM.

Overview of IOM Recommendations about Conflict of Interest in Medicine.

• Institutions engaged in medical research and education, clinical care, and the development of clinical practice guidelines should “adopt and implement conflict of interest policies” and “strengthen disclosure policies.” They and other interested organizations (such as accrediting bodies, health insurers, consumer groups, and government agencies) should standardize the content, formats, and “procedures for the disclosure of financial relationships with industry.”

• Congress “should create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians and other prescribers, biomedical researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education and foundations created by any of these entities.” Until Congress acts, “companies should voluntarily adopt such reporting.”

• Academic medical centers, research institutions, and medical researchers should “restrict participation of researchers with financial conflicts of interest in research with human participants.” Exceptions “should be made public” and occur only if a conflict-of-interest committee “determines that an individual’s participation is essential for the conduct of the research” and if there is “an effective mechanism for managing the conflict and protecting the integrity of the research.”

• Academic medical centers, teaching hospitals, faculty members, students, residents, and fellows should “reform relationships with industry in medical education”; these institutions and professional societies “should provide education on conflict of interest.”

• The organizations that created the accrediting program for continuing medical education and other interested groups should reform the financing system so that it is “free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education.”

• Physicians, professional societies, hospitals, and other health care providers should reform physicians’ financial relationships with industry; the same standards should apply to community physicians, medical school faculty, and trainees. Physicians should forgo all gifts and other “items of material value” from pharmaceutical, medical-device, and biotechnology companies, accepting only “payment at fair market value for a legitimate service” in specified situations. Physicians should “not make educational presentations or publish scientific articles that are controlled by industry or that contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged.” Physicians should “not meet with pharmaceutical and medical device sales representatives except by documented appointment and at the physician’s express invitation” and should “not accept drug samples except in certain situations for patients who lack financial access to medications.” Until institutions change their policies, physicians and trainees “should voluntarily adopt” these recommendations “as standards for their own conduct.”

• Medical companies and their foundations should reform interactions with physicians — for example, by instituting “policies and practices against providing doctors with gifts, meals, drug samples (except for use by patients who lack financial access to medications), or other similar items of material value and against asking physicians to be authors of ghostwritten materials.” Consulting arrangements “should be for necessary services, documented in written contracts, and paid for at fair market value.” Companies “should not involve physicians and patients in marketing projects that are presented as clinical research.”

• Groups that develop clinical practice guidelines should restrict industry funding and conflicts of panel members. Various entities, including accrediting and certification bodies, formulary committees, health insurers, and public agencies should “create incentives for reducing conflicts in clinical practice guideline development.”

• The governing bodies of institutions engaged in medical research, medical education, patient care, or guideline development “should establish their own standing committees on institutional conflicts of interest” that “have no members who themselves have conflicts of interest relevant to the activities of the institution.”

• The National Institutes of Health should revise federal regulations to require research institutions to have policies on institutional conflicts of interest, including “the reporting of identified institutional conflicts of interest and the steps that have been taken to eliminate or manage such conflicts.”

• Oversight bodies and other groups should “provide additional incentives for institutions to adopt and implement” conflict-of-interest policies, such as by publicizing the names of institutions that have instituted the recommended policies and those that have not.

• The Department of Health and Human Services and its agencies should develop and fund research agendas on conflict of interest.

Acceso en

Acceso al informe del IOM:

Comités de ética en investigación comerciales ¿y la ética?

abril 24, 2009

How ethical are for-profit institutional review boards?

The Lancet

Committee on Energy and Commerce

On April 14, the US Food and Drug Administration (FDA) sent a warning letter to Coast IRB of Colorado Springs, CO, a for-profit institutional review board (IRB), in which it outlined serious failings in the company’s processes to approve research studies in human beings. Coast agreed to the FDA’s demand to halt new enrolments to ongoing FDA-regulated studies, to approve no new studies, and to outline plans for corrective actions within 15 days. This letter follows a congressional hearing by a subcommittee of the Committee on Energy and Commerce last month. In that hearing, the findings of a 14-month undercover operation by the US Government Accountability Office (GAO) were discussed. GAO investigated so-called independent IRBs that operate for profit and largely serve industry-funded research in private offices or hospitals. As part of that operation, GAO submitted a fictitious protocol of a high-risk intervention with serious gaps, especially on safety information. The study involved application of 1 L of an ill-defined substance to the abdominal cavity of women after surgery to minimise adhesions. The protocol was sent to three independent IRBs. Two sent it back immediately because of serious safety concerns. Coast IRB approved it unanimously (7:0) with only minor changes, concluding that the intervention is “probably very safe”. In the hearing, the Committee’s Chairman, Henry Waxman, explained how Coast had reviewed 356 protocols in the past 5 years and approved all of them, and all but one unanimously. Coast aggressively marketed its approval as very fast and offered a “get your first one free worth US$1300” coupon, then “coast through your next one”. Its revenue has almost doubled to $9·3 million in the past 4 years. Commercial IRBs approve only a small proportion of all research studies. Yet Coast alone approved 300 studies that are ongoing, and questions remain about how many of these have shortcomings. Protecting research participants is an extremely important part of research governance. Without adequate rigorous oversight, trust in research will be seriously undermined. Commercial considerations must not be allowed to override thorough ethical approval processes.

The Lancet, Volume 373, Issue 9673, Page 1400, 25 April 2009