Schools Group, Not AMA, Says No to Industry Gifts

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Schools Group, Not AMA, Says No to Industry Gifts

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council. The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

At the same time, most medical students have “limited understanding” of such issues. Medical curricula should include information on topics such as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report asserts.

But the report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health.”

The American Medical Association also reviewed industry funding and gifts at its June 14–18 House of Delegates meeting but declined to take a clear-cut position. The AMA's Council on Ethical and Judicial Affairs recommended that individual physicians and institutions of medicine not accept industry funding for education. But the delegates referred the report for further review after the Committee on Amendments to the Constitution and Bylaws said that testimony on the report lacked clarity in some areas. The panel also cited concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted, and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

This newspaper and “The Pink Sheet” are both published by Elsevier.

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Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council. The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

At the same time, most medical students have “limited understanding” of such issues. Medical curricula should include information on topics such as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report asserts.

But the report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health.”

The American Medical Association also reviewed industry funding and gifts at its June 14–18 House of Delegates meeting but declined to take a clear-cut position. The AMA's Council on Ethical and Judicial Affairs recommended that individual physicians and institutions of medicine not accept industry funding for education. But the delegates referred the report for further review after the Committee on Amendments to the Constitution and Bylaws said that testimony on the report lacked clarity in some areas. The panel also cited concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted, and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

This newspaper and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council. The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

At the same time, most medical students have “limited understanding” of such issues. Medical curricula should include information on topics such as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report asserts.

But the report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health.”

The American Medical Association also reviewed industry funding and gifts at its June 14–18 House of Delegates meeting but declined to take a clear-cut position. The AMA's Council on Ethical and Judicial Affairs recommended that individual physicians and institutions of medicine not accept industry funding for education. But the delegates referred the report for further review after the Committee on Amendments to the Constitution and Bylaws said that testimony on the report lacked clarity in some areas. The panel also cited concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted, and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

This newspaper and “The Pink Sheet” are both published by Elsevier.

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Med Schools Oppose Industry Gifts; AMA Sits Out Debate

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Med Schools Oppose Industry Gifts; AMA Sits Out Debate

This newspaper and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness–AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers, though some have not yet taken up the issue.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Drug Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME).

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences. The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

 

 

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

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This newspaper and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness–AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers, though some have not yet taken up the issue.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Drug Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME).

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences. The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

 

 

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

This newspaper and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness–AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers, though some have not yet taken up the issue.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Drug Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME).

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences. The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

 

 

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

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Medical Schools Take Stand Against Industry Gifts

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Medical Schools Take Stand Against Industry Gifts

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness—AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as institutions that have implemented such policies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the "sunshine" approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The medical schools report, titled "Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council," calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Drug Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most students have "limited understanding" of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, "meaning and limitation" of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site.

The report affirms that "substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health," saying that industry and the medical community should work together "to develop new paradigms" for scientific information transfer.

AMA Reviewing Funding Issue

The American Medical Association also reviewed industry funding at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws. The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences.

SKIN & ALLERGY NEWS and "The Pink Sheet" are both published by Elsevier.

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Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness—AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as institutions that have implemented such policies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the "sunshine" approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The medical schools report, titled "Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council," calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Drug Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most students have "limited understanding" of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, "meaning and limitation" of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site.

The report affirms that "substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health," saying that industry and the medical community should work together "to develop new paradigms" for scientific information transfer.

AMA Reviewing Funding Issue

The American Medical Association also reviewed industry funding at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws. The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences.

SKIN & ALLERGY NEWS and "The Pink Sheet" are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness—AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers.

AAMC cites the medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as institutions that have implemented such policies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the "sunshine" approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The medical schools report, titled "Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council," calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Drug Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most students have "limited understanding" of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, "meaning and limitation" of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site.

The report affirms that "substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health," saying that industry and the medical community should work together "to develop new paradigms" for scientific information transfer.

AMA Reviewing Funding Issue

The American Medical Association also reviewed industry funding at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws. The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences.

SKIN & ALLERGY NEWS and "The Pink Sheet" are both published by Elsevier.

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Medical Schools Take Stand Against Industry Gifts

RHEUMATOLOGY NEWS and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness—AAMC notes that many academic institutions are developing policies on interactions with drug and device makers.

AAMC cites medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest in such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME), whether at the medical school or across the street.

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity on certified CME and uncertified promotional education, and concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

 

 

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

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RHEUMATOLOGY NEWS and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness—AAMC notes that many academic institutions are developing policies on interactions with drug and device makers.

AAMC cites medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest in such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME), whether at the medical school or across the street.

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity on certified CME and uncertified promotional education, and concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

 

 

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

RHEUMATOLOGY NEWS and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness—AAMC notes that many academic institutions are developing policies on interactions with drug and device makers.

AAMC cites medical schools at the University of Pittsburgh, the University of Pennsylvania, Stanford University, the University of California at Davis, UCLA, and Yale University as institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest in such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speaking bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME), whether at the medical school or across the street.

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity on certified CME and uncertified promotional education, and concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

 

 

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of AMA's Council on Medical Education to monitor implementation of ACCME standards.

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Thu, 12/06/2018 - 15:36
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Medical Schools Take Stand Against Industry Gifts

This newspaper and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education (CME) activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness. The AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers, though some have not yet taken up the issue.

The AAMC cites the medical schools at the University of Pittsburgh; the University of Pennsylvania; Stanford University; the University of California, Davis, University of California, Los Angeles; and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

The AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to the AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples, or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speakers bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME), whether at the medical school or across the street.

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for the AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

 

 

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of the AMA's Council on Medical Education to monitor implementation of ACCME standards.

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This newspaper and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education (CME) activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness. The AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers, though some have not yet taken up the issue.

The AAMC cites the medical schools at the University of Pittsburgh; the University of Pennsylvania; Stanford University; the University of California, Davis, University of California, Los Angeles; and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

The AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to the AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples, or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speakers bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME), whether at the medical school or across the street.

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for the AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

 

 

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of the AMA's Council on Medical Education to monitor implementation of ACCME standards.

This newspaper and “The Pink Sheet” are both published by Elsevier.

Medical schools and teaching hospitals should prohibit their physicians, faculty, residents, and students from taking gifts and services from drug companies, according to the Association of American Medical Colleges.

Industry support for continuing medical education (CME) activities also should be limited, according to a report unanimously adopted by the AAMC executive council.

The association is urging member institutions to adopt policies consistent with the report by July 1, 2009.

Many Schools Are Studying Gifts Issue

The recommendations might be particularly influential because of their timeliness. The AAMC notes that many academic institutions are in the midst of developing policies on interactions with drug and device manufacturers, though some have not yet taken up the issue.

The AAMC cites the medical schools at the University of Pittsburgh; the University of Pennsylvania; Stanford University; the University of California, Davis, University of California, Los Angeles; and Yale University as among the institutions that have implemented policies in the past few years.

The association represents 129 U.S. and 17 Canadian medical schools, about 400 teaching hospitals and health systems, and a number of scientific societies.

The AAMC's strong stance against industry gifts to physicians comes as drug and device makers are signing on to federal legislation that would bring transparency to their financial interactions with doctors by requiring public disclosure of gifts.

But the “sunshine” approach might prove to be temporary. In addition to the AAMC's call for a ban, the Massachusetts Senate adopted a bill in April that would ban pharmaceutical industry gifts of any value to physicians, their office staffs, or their families.

The Institute of Medicine also is assessing the effectiveness of transparency in preventing conflicts of interest arising from such interactions, with a report due in July 2009.

The medical schools report, titled “Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council,” calls on members to take the following actions:

▸ Ban acceptance of industry gifts by doctors, faculty, students, and residents, whether given on- or off-site.

▸ Either end acceptance of drug samples, or manage their distribution through a centralized process.

▸ Restrict visits to individual doctors by industry representatives to nonpatient areas and by appointment only.

▸ Create a central office to receive and coordinate distribution of industry support for CME.

▸ Strongly discourage faculty participation in industry-sponsored speakers bureaus.

▸ Bar physicians, residents, and students from using presentations ghostwritten by industry members.

Lessons on the Nature of the Industry

The group also notes that medical students often take their cue from faculty and medical residents, suggesting that those in a mentoring role must lead by example in industry interactions. At the same time, most medical students have “limited understanding” of such issues as the process of drug development, nature of the pharmaceutical industry, product marketing, “meaning and limitation” of FDA product approval, and physician role in adverse event reporting, the report notes. Medical curricula should include information on these topics.

The report also emphasizes that while academic institutions are not responsible for policing activities outside their facilities, faculty and students should be advised that prohibited activities are also barred off-site. For example, they should not accept meals from industry (outside of officially sanctioned CME), whether at the medical school or across the street.

The report affirms that “substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to the public health,” saying that industry and the medical community should work together “to develop new paradigms” for scientific information transfer.

The Accreditation Council for Continuing Medical Education is seeking comments on such a paradigm with regard to industry support for CME.

AMA Awaits Federal Legislation

The American Medical Association also has been reviewing industry funding and gifts at its annual House of Delegates meeting but declined to take a clear-cut position. Its Council on Ethical and Judicial Affairs drafted a report recommending that individual physicians and institutions of medicine not accept industry funding for education.

But during their June 14-18 session, the AMA delegates referred the report for further review at the recommendation of the group's Committee on Amendments to the Constitution and Bylaws.

The panel said testimony on the report noted a lack of clarity with regard to certified CME and uncertified promotional education, and concern for unintended consequences.

The delegates also declined to get embroiled in the debate over reporting of industry gifts. Pending was a resolution for the AMA to back annual reporting by drug and medical device firms of all physician payments with a value of more than $100.

 

 

An AMA committee advised delegates that testimony on the measure generally was unfavorable, with concerns raised about the logistics and how and to whom the information would be disclosed.

Noting that legislation on the issue “is pending and may serve to answer many of these questions,” the committee recommended that the resolution not be adopted and the delegates concurred.

On the question of conflicts of interest in CME, the delegates accepted the recommendation of the AMA's Council on Medical Education to monitor implementation of ACCME standards.

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Are Bisphosphonates, Heart Disorder Linked?

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Are Bisphosphonates, Heart Disorder Linked?

The Food and Drug Administration will seek data for an “in-depth evaluation” of atrial fibrillation for the entire bisphosphonate class of drugs as well as continue to monitor any spontaneous postmarketing reports of the heart rhythm disorder, agency officials announced on Oct. 1.

FDA is not recommending at this point that physicians alter their prescribing choices or that patients change their medications.

The review encompasses products approved primarily to treat osteoporosis, slow bone turnover in Paget's disease, and treat bone metastases in cancer patients—specifically alendronate (Fosamax and Fosamax Plus D), risedronate (Actonel and Actonel with Calcium), ibandronate (Boniva), zoledronic acid (Reclast and Zometa), pamidronate (Aredia), and etidronate.

The evaluation follows publication of two studies describing increased rates of serious atrial fibrillation in older women treated with zoledronic acid or alendronate for osteoporosis (N. Engl. J. Med. 2007;356:1809–33 and N. Engl. J. Med. 2007;356:1895–6). In those studies, researchers found that more women who received one of the bisphosphonates developed serious atrial fibrillation versus those receiving placebo, according to the FDA announcement, which noted that overall rates of atrial fibrillation were not statistically different between the studies' active treatment and placebo arms.

Upon reviewing its postmarketing reports of atrial fibrillation in association with both oral and intravenous bisphosphonates, the agency did not find a “population of bisphosphonates users at increased risk” for the atrial fibrillation. And since atrial fibrillation is a common disorder in patients over age 65 years—the same population that was studied in the New England Journal of Medicine articles—the FDA cautioned that it is “unclear how these data … should be interpreted.”

Further, the FDA's recent review and approval of zoledronic acid included data on possible associations with atrial fibrillation, the agency said.

Those reviews found that most incidents occurred more than a month after infusion of the drug, which is administered once yearly to treat postmenopausal osteoporosis.

The in-depth review may take up to 12 months, according to the FDA. This is the agency's second “early communication” of a drug safety review, part of FDA's efforts to be more transparent in oversight of postmarketing drug safety. The first communication, which was released in August, addressed the proton pump inhibitors omeprazole and esomeprazole.

This newspaper and “The Pink Sheet” are published by Elsevier.

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The Food and Drug Administration will seek data for an “in-depth evaluation” of atrial fibrillation for the entire bisphosphonate class of drugs as well as continue to monitor any spontaneous postmarketing reports of the heart rhythm disorder, agency officials announced on Oct. 1.

FDA is not recommending at this point that physicians alter their prescribing choices or that patients change their medications.

The review encompasses products approved primarily to treat osteoporosis, slow bone turnover in Paget's disease, and treat bone metastases in cancer patients—specifically alendronate (Fosamax and Fosamax Plus D), risedronate (Actonel and Actonel with Calcium), ibandronate (Boniva), zoledronic acid (Reclast and Zometa), pamidronate (Aredia), and etidronate.

The evaluation follows publication of two studies describing increased rates of serious atrial fibrillation in older women treated with zoledronic acid or alendronate for osteoporosis (N. Engl. J. Med. 2007;356:1809–33 and N. Engl. J. Med. 2007;356:1895–6). In those studies, researchers found that more women who received one of the bisphosphonates developed serious atrial fibrillation versus those receiving placebo, according to the FDA announcement, which noted that overall rates of atrial fibrillation were not statistically different between the studies' active treatment and placebo arms.

Upon reviewing its postmarketing reports of atrial fibrillation in association with both oral and intravenous bisphosphonates, the agency did not find a “population of bisphosphonates users at increased risk” for the atrial fibrillation. And since atrial fibrillation is a common disorder in patients over age 65 years—the same population that was studied in the New England Journal of Medicine articles—the FDA cautioned that it is “unclear how these data … should be interpreted.”

Further, the FDA's recent review and approval of zoledronic acid included data on possible associations with atrial fibrillation, the agency said.

Those reviews found that most incidents occurred more than a month after infusion of the drug, which is administered once yearly to treat postmenopausal osteoporosis.

The in-depth review may take up to 12 months, according to the FDA. This is the agency's second “early communication” of a drug safety review, part of FDA's efforts to be more transparent in oversight of postmarketing drug safety. The first communication, which was released in August, addressed the proton pump inhibitors omeprazole and esomeprazole.

This newspaper and “The Pink Sheet” are published by Elsevier.

The Food and Drug Administration will seek data for an “in-depth evaluation” of atrial fibrillation for the entire bisphosphonate class of drugs as well as continue to monitor any spontaneous postmarketing reports of the heart rhythm disorder, agency officials announced on Oct. 1.

FDA is not recommending at this point that physicians alter their prescribing choices or that patients change their medications.

The review encompasses products approved primarily to treat osteoporosis, slow bone turnover in Paget's disease, and treat bone metastases in cancer patients—specifically alendronate (Fosamax and Fosamax Plus D), risedronate (Actonel and Actonel with Calcium), ibandronate (Boniva), zoledronic acid (Reclast and Zometa), pamidronate (Aredia), and etidronate.

The evaluation follows publication of two studies describing increased rates of serious atrial fibrillation in older women treated with zoledronic acid or alendronate for osteoporosis (N. Engl. J. Med. 2007;356:1809–33 and N. Engl. J. Med. 2007;356:1895–6). In those studies, researchers found that more women who received one of the bisphosphonates developed serious atrial fibrillation versus those receiving placebo, according to the FDA announcement, which noted that overall rates of atrial fibrillation were not statistically different between the studies' active treatment and placebo arms.

Upon reviewing its postmarketing reports of atrial fibrillation in association with both oral and intravenous bisphosphonates, the agency did not find a “population of bisphosphonates users at increased risk” for the atrial fibrillation. And since atrial fibrillation is a common disorder in patients over age 65 years—the same population that was studied in the New England Journal of Medicine articles—the FDA cautioned that it is “unclear how these data … should be interpreted.”

Further, the FDA's recent review and approval of zoledronic acid included data on possible associations with atrial fibrillation, the agency said.

Those reviews found that most incidents occurred more than a month after infusion of the drug, which is administered once yearly to treat postmenopausal osteoporosis.

The in-depth review may take up to 12 months, according to the FDA. This is the agency's second “early communication” of a drug safety review, part of FDA's efforts to be more transparent in oversight of postmarketing drug safety. The first communication, which was released in August, addressed the proton pump inhibitors omeprazole and esomeprazole.

This newspaper and “The Pink Sheet” are published by Elsevier.

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Are Bisphosphonates, Heart Disorder Linked?
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