Clarification of Reporting of Potential Conflicts of Interest in JAMA Articles

Clarification of Reporting of Potential Conflicts of Interest in JAMA Articles Letters 1,2 their best to know and implement the main recommenda- For 2 of these articles, my disclosure statement should tions in the guidelines. An ongoing trial, A Clinical Trial of Statin have read as follows: “Dr Dzau reports having served previ- Therapy for Reducing Events in the Elderly (STAREE), is study- ously as a member of the board of Medtronic Inc ending in June ing the effects of 40 mg of atorvastatin daily for primary pre- 2014 and receiving compensation from that company.” For the vention in 18 000 patients aged 70 years or older. Treatment third article, my disclosure statement should have read as fol- with a statin is being compared with placebo on prolonging lows: “Dr Dzau reports having served previously as a mem- overall survival or disability-free survival. Hopefully this trial ber of the board of Alnylam Pharmaceuticals ending in June will provide information regarding the effect of statins on older 2014 and receiving compensation from that company.” I have adults. Until such evidence becomes available, the clearest and requested that these articles be corrected online. most accurate way to phrase a recommendation for older adults might have been, “In adults 75 years of age and older, the ef- Victor J. Dzau, MD fectiveness of initiating a moderate-intensity statin for pri- Author Affiliation: National Academy of Medicine, Washington, DC. mary prevention is not well established.” Corresponding Author: Victor J. Dzau, MD, National Academy of Medicine, 500 Fifth St NW, Washington, DC 20001 (vdzau@nas.edu). Neil Skolnik, MD Published Online: July 16, 2019. doi:10.1001/jama.2019.11051 Conflict of Interest Disclosures: No additional disclosures were reported. Author Affiliation: Family Medicine, Abington-Jefferson Health, Jenkintown, Pennsylvania. 1. Dzau VJ, Pizzo PA. Relieving pain in America: insights from an Institute of Medicine committee. JAMA. 2014;312(15):1507-1508. doi:10.1001/jama.2014.12986 Corresponding Author: Neil Skolnik, MD, Abington Family Medicine, 500 Old York Rd, Ste 108, Jenkintown, PA 19025 (mskolnik@comcast.net). 2. Leshner AI, Dzau VJ. Medication-based treatment to address opioid use disorder. JAMA. 2019;321(21):2071-2072. doi:10.1001/jama.2019.5523 Conflict of Interest Disclosures: Dr Skolnik reported receiving nonfinancial support from AstraZeneca, Boehringer Ingelheim, Sanofi, and GlaxoSmithKline 3. Dzau VJ, Ginsburg GS. Realizing the full potential of precision medicine in and receiving personal fees from and serving on advisory boards of health and health care. JAMA. 2016;316(16):1659-1660. doi:10.1001/jama.2016. AstraZeneca, Boehringer Ingelheim, Teva Pharmaceutical, Eli Lilly, Sanofi, Janssen Pharmaceuticals, Intarcia, Mylan, GlaxoSmithKline, and Merck. 4. Clarification of reporting of potential conflicts of interest [correction]. 1. Skolnik N. Reexamining recommendations for treatment of Published online July 16, 2019. JAMA. doi:10.1001/jama.2019.11017 hypercholesterolemia in older adults. JAMA. 2019;321(13):1249-1250. doi:10. 1001/jama.2019.1676 CORRECTION 2. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of ClarificationofReportingofPotentialConflictsofInterest: In 3 Viewpoints pub- blood cholesterol: executive summary: a report of the American College of 1-3 lished in JAMA, additional information was needed to clarify the conflict of in- Cardiology/American Heart Association Task Force on Clinical Practice terest disclosures. The Conflict of Interest Disclosures statements in 2 of the Guidelines. J Am Coll Cardiol. 2018;S0735-1097(18):39033-39038. doi:10.1016/ 1,2 Viewpoints should have read as follows: “Dr Dzau reports having served previ- j.jacc.2018.11.002 ously as a member of the board of Medtronic Inc ending in June 2014 and receiv- 3. Pickering TG. Now we are sick: labeling and hypertension. J Clin Hypertens ing compensation from that company.” For the third Viewpoint, the disclosure (Greenwich). 2006;8(1):57-60. doi:10.1111/j.1524-6175.2005.05121.x statement should have read as follows: “Dr Dzau reports having served previ- ously as a member of the board of Alnylam Pharmaceuticals ending in June 2014 4. A Clinical Trial of Statin Therapy for Reducing Events in the Elderly (STAREE). and receiving compensation from that company.” These articles have been cor- ClinicalTrials.gov Identifier: NCT02099123. https://clinicaltrials.gov/ct2/show/ rected online and a letter of explanation has also been published for further clari- NCT02099123. Updated March 12, 2019. Accessed May 12, 2019. fication. 1. Dzau VJ, Pizzo PA. Relieving pain in America: insights from an Institute of Medicine committee. JAMA. 2014;312(15):1507-1508. doi:10.1001/jama.2014.12986 Clarification of Reporting of Potential Conflicts of Interest in JAMA Articles 2. Leshner AI, Dzau VJ. Medication-based treatment to address opioid use disorder. JAMA. 2019;321(21):2071-2072. doi:10.1001/jama.2019.5523 To the Editor I am writing to provide additional information to 3. Dzau VJ, Ginsburg GS. Realizing the full potential of precision medicine in clarify conflict of interest disclosures in articles I published in health and health care. JAMA. 2016;316(16):1659-1660. doi:10.1001/jama.2016. JAMA in 2014, 2016, and 2019. In February 2014, I was selected to become the president 4. Dzau VJ. Clarification of reporting of potential conflicts of interest in JAMA of the Institute of Medicine, now known as the National Acad- articles [published online July 16, 2019]. JAMA. doi:10.1001/jama.2019.11051 emy of Medicine (NAM). Between that time and July 1, 2014, my first day of service, I resigned all positions and relation- Numbers of Patients Transposed in Text: In the Original Investigation entitled ships with industry and sold health care–related stocks to elimi- “Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous nate all potential financial conflicts of interest. Prior to becom- Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial,” published in the June 11, 2019, issue of ing president of the Institute of Medicine, I was a member of JAMA, patient numbers were transposed in a sentence in the Results section of the board of directors of Medtronic Inc and Alnylam Pharma- the text. The first sentence in the Secondary Outcomes subsection on page 2178 ceuticals Inc. As previously disclosed to and approved by NAM, should have read “After the first SBT, 532 patients (92.5%) undergoing the 30- I have received deferred stock compensation for past board ser- minute PSV SBT and 486 patients (84.1%) undergoing the 2-hour T-piece SBT were extubated (difference, 8.4%; 95% CI, 4.7%-12.1%; P < .001).” This article was cor- vices prior to July 2014. Because Medtronic makes a device that rected online. could be used to treat or manage pain, and because Alnylam 1. Subirà C, Hernández G, Vázquez A, et al. Effect of pressure support vs T-piece makes products for targeted gene therapy, in the spirit of trans- ventilation strategies during spontaneous breathing trials on successful parency and abundance of caution, it would have been helpful extubation among patients receiving mechanical ventilation: a randomized for those past relationships to have been disclosed. clinical trial. JAMA. 2019;321(22):2175-2182. doi:10.1001/jama.2019.7234 696 JAMA August 20, 2019 Volume 322, Number 7 (Reprinted) jama.com © 2019 American Medical Association. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Clarification of Reporting of Potential Conflicts of Interest in JAMA Articles

JAMA, Volume 322 (7) – Aug 20, 2019

Loading next page...
 
/lp/american-medical-association/clarification-of-reporting-of-potential-conflicts-of-interest-in-jama-tI4J0XB3xZ
Publisher
American Medical Association
Copyright
Copyright 2019 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2019.11051
Publisher site
See Article on Publisher Site

Abstract

Letters 1,2 their best to know and implement the main recommenda- For 2 of these articles, my disclosure statement should tions in the guidelines. An ongoing trial, A Clinical Trial of Statin have read as follows: “Dr Dzau reports having served previ- Therapy for Reducing Events in the Elderly (STAREE), is study- ously as a member of the board of Medtronic Inc ending in June ing the effects of 40 mg of atorvastatin daily for primary pre- 2014 and receiving compensation from that company.” For the vention in 18 000 patients aged 70 years or older. Treatment third article, my disclosure statement should have read as fol- with a statin is being compared with placebo on prolonging lows: “Dr Dzau reports having served previously as a mem- overall survival or disability-free survival. Hopefully this trial ber of the board of Alnylam Pharmaceuticals ending in June will provide information regarding the effect of statins on older 2014 and receiving compensation from that company.” I have adults. Until such evidence becomes available, the clearest and requested that these articles be corrected online. most accurate way to phrase a recommendation for older adults might have been, “In adults 75 years of age and older, the ef- Victor J. Dzau, MD fectiveness of initiating a moderate-intensity statin for pri- Author Affiliation: National Academy of Medicine, Washington, DC. mary prevention is not well established.” Corresponding Author: Victor J. Dzau, MD, National Academy of Medicine, 500 Fifth St NW, Washington, DC 20001 (vdzau@nas.edu). Neil Skolnik, MD Published Online: July 16, 2019. doi:10.1001/jama.2019.11051 Conflict of Interest Disclosures: No additional disclosures were reported. Author Affiliation: Family Medicine, Abington-Jefferson Health, Jenkintown, Pennsylvania. 1. Dzau VJ, Pizzo PA. Relieving pain in America: insights from an Institute of Medicine committee. JAMA. 2014;312(15):1507-1508. doi:10.1001/jama.2014.12986 Corresponding Author: Neil Skolnik, MD, Abington Family Medicine, 500 Old York Rd, Ste 108, Jenkintown, PA 19025 (mskolnik@comcast.net). 2. Leshner AI, Dzau VJ. Medication-based treatment to address opioid use disorder. JAMA. 2019;321(21):2071-2072. doi:10.1001/jama.2019.5523 Conflict of Interest Disclosures: Dr Skolnik reported receiving nonfinancial support from AstraZeneca, Boehringer Ingelheim, Sanofi, and GlaxoSmithKline 3. Dzau VJ, Ginsburg GS. Realizing the full potential of precision medicine in and receiving personal fees from and serving on advisory boards of health and health care. JAMA. 2016;316(16):1659-1660. doi:10.1001/jama.2016. AstraZeneca, Boehringer Ingelheim, Teva Pharmaceutical, Eli Lilly, Sanofi, Janssen Pharmaceuticals, Intarcia, Mylan, GlaxoSmithKline, and Merck. 4. Clarification of reporting of potential conflicts of interest [correction]. 1. Skolnik N. Reexamining recommendations for treatment of Published online July 16, 2019. JAMA. doi:10.1001/jama.2019.11017 hypercholesterolemia in older adults. JAMA. 2019;321(13):1249-1250. doi:10. 1001/jama.2019.1676 CORRECTION 2. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of ClarificationofReportingofPotentialConflictsofInterest: In 3 Viewpoints pub- blood cholesterol: executive summary: a report of the American College of 1-3 lished in JAMA, additional information was needed to clarify the conflict of in- Cardiology/American Heart Association Task Force on Clinical Practice terest disclosures. The Conflict of Interest Disclosures statements in 2 of the Guidelines. J Am Coll Cardiol. 2018;S0735-1097(18):39033-39038. doi:10.1016/ 1,2 Viewpoints should have read as follows: “Dr Dzau reports having served previ- j.jacc.2018.11.002 ously as a member of the board of Medtronic Inc ending in June 2014 and receiv- 3. Pickering TG. Now we are sick: labeling and hypertension. J Clin Hypertens ing compensation from that company.” For the third Viewpoint, the disclosure (Greenwich). 2006;8(1):57-60. doi:10.1111/j.1524-6175.2005.05121.x statement should have read as follows: “Dr Dzau reports having served previ- ously as a member of the board of Alnylam Pharmaceuticals ending in June 2014 4. A Clinical Trial of Statin Therapy for Reducing Events in the Elderly (STAREE). and receiving compensation from that company.” These articles have been cor- ClinicalTrials.gov Identifier: NCT02099123. https://clinicaltrials.gov/ct2/show/ rected online and a letter of explanation has also been published for further clari- NCT02099123. Updated March 12, 2019. Accessed May 12, 2019. fication. 1. Dzau VJ, Pizzo PA. Relieving pain in America: insights from an Institute of Medicine committee. JAMA. 2014;312(15):1507-1508. doi:10.1001/jama.2014.12986 Clarification of Reporting of Potential Conflicts of Interest in JAMA Articles 2. Leshner AI, Dzau VJ. Medication-based treatment to address opioid use disorder. JAMA. 2019;321(21):2071-2072. doi:10.1001/jama.2019.5523 To the Editor I am writing to provide additional information to 3. Dzau VJ, Ginsburg GS. Realizing the full potential of precision medicine in clarify conflict of interest disclosures in articles I published in health and health care. JAMA. 2016;316(16):1659-1660. doi:10.1001/jama.2016. JAMA in 2014, 2016, and 2019. In February 2014, I was selected to become the president 4. Dzau VJ. Clarification of reporting of potential conflicts of interest in JAMA of the Institute of Medicine, now known as the National Acad- articles [published online July 16, 2019]. JAMA. doi:10.1001/jama.2019.11051 emy of Medicine (NAM). Between that time and July 1, 2014, my first day of service, I resigned all positions and relation- Numbers of Patients Transposed in Text: In the Original Investigation entitled ships with industry and sold health care–related stocks to elimi- “Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous nate all potential financial conflicts of interest. Prior to becom- Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial,” published in the June 11, 2019, issue of ing president of the Institute of Medicine, I was a member of JAMA, patient numbers were transposed in a sentence in the Results section of the board of directors of Medtronic Inc and Alnylam Pharma- the text. The first sentence in the Secondary Outcomes subsection on page 2178 ceuticals Inc. As previously disclosed to and approved by NAM, should have read “After the first SBT, 532 patients (92.5%) undergoing the 30- I have received deferred stock compensation for past board ser- minute PSV SBT and 486 patients (84.1%) undergoing the 2-hour T-piece SBT were extubated (difference, 8.4%; 95% CI, 4.7%-12.1%; P < .001).” This article was cor- vices prior to July 2014. Because Medtronic makes a device that rected online. could be used to treat or manage pain, and because Alnylam 1. Subirà C, Hernández G, Vázquez A, et al. Effect of pressure support vs T-piece makes products for targeted gene therapy, in the spirit of trans- ventilation strategies during spontaneous breathing trials on successful parency and abundance of caution, it would have been helpful extubation among patients receiving mechanical ventilation: a randomized for those past relationships to have been disclosed. clinical trial. JAMA. 2019;321(22):2175-2182. doi:10.1001/jama.2019.7234 696 JAMA August 20, 2019 Volume 322, Number 7 (Reprinted) jama.com © 2019 American Medical Association. All rights reserved.

Journal

JAMAAmerican Medical Association

Published: Aug 20, 2019

References

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create folders to
organize your research

Export folders, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off