Institute of Medicine: Conflict of Interest in Medical, Research, Education and Practice
The Institute of Medicine: Conflict of Interest In Medical Research, Education and Practice Full Report and Press Release came out today and the report is over 300 pages long.
The report though lengthy is a re-hash of many of the themes we have seen from conflict of interest experts in the past few years, but the recommendations are presented with noticeable restraint. It is clear that they have given consideration to what will happen if we pull out all industry ties with industry and that will be very difficult.
Unfortunately their press conference on the report was a frontal assualt on all industry relationships with physicians and the presenters all conflict of interest experts (no practicing physicians), were on a one upmanship journey to see who is the most anti industry.
Bellow is a summary of the policy recommendations, which are not intended for the general reading audience.
Policy Recommendations:
3.1 Calls on all institutions engaged in these activities to establish conflict of interest policies and create conflict of interest committees to evaluate and manage conflicts.
3.2 Focuses on the essential policy step of requiring physicians, researchers, and senior officials to disclose to their institutions their financial relationships with industry.
3.3 Calls for the standardization of disclosures with the goals of providing institutions with the specific information that they need to assess relationships while reducing the reporting burdens on physicians and researchers.
3.4 Calls for the U.S. Congress to create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians, 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.
Research:
4.1 Calls for a general rule that researchers may not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial. Exceptions should be allowed only if an individual’s participation is judged to be essential for the safe and appropriate conduct of the research.
Education:
5.1: Therefore calls on academic medical centers to prohibit faculty, students, residents, and fellows from accepting gifts (including meals), making presentations that are controlled by industry, and claiming authorship for ghostwritten publications. This restriction is not intended to exclude the acceptance of scientific materials from industry scientists under-appropriate material transfer agreements or the payment of reasonable honoraria to speakers who present their own material. Recommendation 5.1 also calls for restrictions on the acceptance of pharmaceutical samples and visits by drug and medical device sales representatives
5.2 Calls on academic medical centers and teaching hospitals, as part of their educational mission, to provide education on the avoidance of conflicts of interest and the management of relationships with pharmaceutical and medical device industry representatives. Organizations that accredit medical schools and residency programs should develop standards to reinforce this
recommendation.
5.3 Calls for a broad-based consensus development process to propose a new system of funding accredited continuing medical education that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education.
Some members of the committee supported a total end to industry funding, but others were concerned about the potential for unintended harm from such a ban. The committee recognized that changes in the current system likely would substantially reduce industry funding for accredited continuing medical education. Even if education providers trim their expenses, the costs of accredited continuing medical education would likely increase for many physicians, which could be an economic burden for some physicians, for example, those in rural areas.
Practice
6.1 (for faculty, students, residents, and fellows). Independent assessment of the evidence and the practice of evidence-based medicine are core competencies for physicians in clinical practice as well as academic practice; relationships with industry should not undermine those competencies.
6.2 Calls for further revisions to industry practices to be consistent with those outlined in Recommendation 6.1
Guidelines:
7.1 Calls on groups that develop guidelines not to accept direct funding for guideline development from industry and generally to exclude individuals with conflicts of interest from guideline development panels.
7.2 Calls for organizations that have an interest in the use of evidence based clinical practice guidelines to establish incentives to encourage the developers of guidelines to adopt the committee’s recommendations.
Institutions
8.1 Calls for the boards of trustees of institutions to establish a conflict of interest committee to make judgments about institutional relationships with industry, including the relationships of senior officials.
8.2 Calls for NIH to develop regulations requiring institutions covered by the 1995 PHS regulations to adopt institutional conflict of interest policies.
Supporting Organizations:
9.1 Proposes that groups such as accrediting organizations, public and private health insurers, and associations of medical journal editors develop incentives to make institutions more accountable for preventing, identifying, and managing conflicts of interest.
9.2, Calls for more research to assess the positive and negative consequences of
conflict of interest policies and provide a stronger evidence base for improving conflict of interest policies and their application
Overall this is a full throttled rehash of conflict of interest recommendations and it is clear from the tables that there is not a lot of evidence to back it up. This report also could be tilted the economic stimulus package for conflict of interest experts, and the creation of conflict of interest jobs throughout the medical community.
The report also basically re-enforces the changes that PhRMA and AdvaMED have made with their codes of conduct, and the AAMC report on conflict of interest in medical education.
We will have a lot more to say once we work our way through the entire report….
The Institute of Medicine:
Conflict of Interest In Medical Research, Education and Practice Full Report
IOM Press Conference (Audio)
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Institute of Medicine: Conflict of Interest in Medical, Research, Education and Practice – Policy and Medicine