Promotional Tone in Reviews of Menopausal Hormone Therapy After the Women's Health Initiative: An Analysis of Published Articles
Background:
Even after the Women's Health Initiative (WHI) found that the risks of menopausal hormone therapy (hormone therapy) outweighed benefit for asymptomatic women, about half of gynecologists in the United States continued to believe that hormones benefited women's health. The pharmaceutical industry has supported publication of articles in medical journals for marketing purposes. It is unknown whether author relationships with industry affect promotional tone in articles on hormone therapy. The goal of this study was to determine whether promotional tone could be identified in narrative review articles regarding menopausal hormone therapy and whether articles identified as promotional were more likely to have been authored by those with conflicts of interest with manufacturers of menopausal hormone therapy.
Methods and Findings:
We analyzed tone in opinion pieces on hormone therapy published in the four years after the estrogen-progestin arm of the WHI was stopped. First, we identified the ten authors with four or more MEDLINE-indexed reviews, editorials, comments, or letters on hormone replacement therapy or menopausal hormone therapy published between July 2002 and June 2006. Next, we conducted an additional search using the names of these authors to identify other relevant articles. Finally, after author names and affiliations were removed, 50 articles were evaluated by three readers for scientific accuracy and for tone. Scientific accuracy was assessed based on whether or not the findings of the WHI were accurately reported using two criteria: (1) Acknowledgment or lack of denial of the risk of breast cancer diagnosis associated with hormone therapy, and (2) acknowledgment that hormone therapy did not benefit cardiovascular disease endpoints. Determination of promotional tone was based on the assessment by each reader of whether the article appeared to promote hormone therapy. Analysis of inter-rater consistency found moderate agreement for scientific accuracy (κ = 0.57) and substantial agreement for promotional tone (κ = 0.65). After discussion, readers found 86% of the articles to be scientifically accurate and 64% to be promotional in tone. Themes that were common in articles considered promotional included attacks on the methodology of the WHI, arguments that clinical trial results should not guide treatment for individuals, and arguments that observational studies are as good as or better than randomized clinical trials for guiding clinical decisions. The promotional articles we identified also implied that the risks associated with hormone therapy have been exaggerated and that the benefits of hormone therapy have been or will be proven. Of the ten authors studied, eight were found to have declared payment for speaking or consulting on behalf of menopausal hormone manufacturers or for research support (seven of these eight were speakers or consultants). Thirty of 32 articles (90%) evaluated as promoting hormone therapy were authored by those with potential financial conflicts of interest, compared to 11 of 18 articles (61%) by those without such conflicts (p = 0.0025). Articles promoting the use of menopausal hormone therapy were 2.41 times (95% confidence interval 1.49–4.93) as likely to have been authored by authors with conflicts of interest as by authors without conflicts of interest. In articles from three authors with conflicts of interest some of the same text was repeated word-for-word in different articles.
Conclusion:
There may be a connection between receiving industry funding for speaking, consulting, or research and the publication of promotional opinion pieces on menopausal hormone therapy.
: Please see later in the article for the Editors' Summary
Vyšlo v časopise:
Promotional Tone in Reviews of Menopausal Hormone Therapy After the Women's Health Initiative: An Analysis of Published Articles. PLoS Med 8(3): e32767. doi:10.1371/journal.pmed.1000425
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1000425
Souhrn
Background:
Even after the Women's Health Initiative (WHI) found that the risks of menopausal hormone therapy (hormone therapy) outweighed benefit for asymptomatic women, about half of gynecologists in the United States continued to believe that hormones benefited women's health. The pharmaceutical industry has supported publication of articles in medical journals for marketing purposes. It is unknown whether author relationships with industry affect promotional tone in articles on hormone therapy. The goal of this study was to determine whether promotional tone could be identified in narrative review articles regarding menopausal hormone therapy and whether articles identified as promotional were more likely to have been authored by those with conflicts of interest with manufacturers of menopausal hormone therapy.
Methods and Findings:
We analyzed tone in opinion pieces on hormone therapy published in the four years after the estrogen-progestin arm of the WHI was stopped. First, we identified the ten authors with four or more MEDLINE-indexed reviews, editorials, comments, or letters on hormone replacement therapy or menopausal hormone therapy published between July 2002 and June 2006. Next, we conducted an additional search using the names of these authors to identify other relevant articles. Finally, after author names and affiliations were removed, 50 articles were evaluated by three readers for scientific accuracy and for tone. Scientific accuracy was assessed based on whether or not the findings of the WHI were accurately reported using two criteria: (1) Acknowledgment or lack of denial of the risk of breast cancer diagnosis associated with hormone therapy, and (2) acknowledgment that hormone therapy did not benefit cardiovascular disease endpoints. Determination of promotional tone was based on the assessment by each reader of whether the article appeared to promote hormone therapy. Analysis of inter-rater consistency found moderate agreement for scientific accuracy (κ = 0.57) and substantial agreement for promotional tone (κ = 0.65). After discussion, readers found 86% of the articles to be scientifically accurate and 64% to be promotional in tone. Themes that were common in articles considered promotional included attacks on the methodology of the WHI, arguments that clinical trial results should not guide treatment for individuals, and arguments that observational studies are as good as or better than randomized clinical trials for guiding clinical decisions. The promotional articles we identified also implied that the risks associated with hormone therapy have been exaggerated and that the benefits of hormone therapy have been or will be proven. Of the ten authors studied, eight were found to have declared payment for speaking or consulting on behalf of menopausal hormone manufacturers or for research support (seven of these eight were speakers or consultants). Thirty of 32 articles (90%) evaluated as promoting hormone therapy were authored by those with potential financial conflicts of interest, compared to 11 of 18 articles (61%) by those without such conflicts (p = 0.0025). Articles promoting the use of menopausal hormone therapy were 2.41 times (95% confidence interval 1.49–4.93) as likely to have been authored by authors with conflicts of interest as by authors without conflicts of interest. In articles from three authors with conflicts of interest some of the same text was repeated word-for-word in different articles.
Conclusion:
There may be a connection between receiving industry funding for speaking, consulting, or research and the publication of promotional opinion pieces on menopausal hormone therapy.
: Please see later in the article for the Editors' Summary
Zdroje
1. PowerML
SchulkinJ
RossouwJE
2007 Evolving practice patterns and attitudes toward hormone therapy of obstetrician-gynecologists. Menopause 14 20 28
2. PowerML
BaronJ
SchulkinJ
2008 Factors associated with obstetrician-gynecologists' response to the Women's Health Initiative trial of combined hormone therapy. Med Decis Making 28 411 418
3. PowerML
AndersonBL
SchulkinJ
2009 Attitudes of obstetrician-gynecologists toward the evidence from the Women's Health Initiative hormone therapy trials remain generally skeptical. Menopause 16 500 508
4. RossouwJE
AndersonGL
PrenticeRL
LaCroixAZ
KooperbergC
2002 Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial. JAMA 288 321 333
5. The Women's Health Initiative Steering C 2004 Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The Women's Health Initiative randomized controlled trial. JAMA 291 1701 1712
6. ShumakerSA
LegaultC
KullerL
RappSR
ThalL
2004 Conjugated equine estrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Women's Health Initiative Memory Study. JAMA 291 2947 58
7. HendrixSL
CochraneBB
NygaardIE
HandaVL
BarnabeiVM
2005 Effects of estrogen with and without progestin on urinary incontinence. JAMA 293 935 48
8. HaysJ
OckeneJK
BrunnerRL
KotchenJM
MansonJE
2003 Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 348 1839 1854
9. BrunnerRL
GassM
AragakiA
HaysJ
GranekI
2005 Effects of conjugated equine estrogen on health-related quality of life in postmenopausal women with hysterectomy: Results from the Women's Health Initiative randomized clinical trial. Arch Intern Med 165 1976 1986
10. MajumdarSR
AlmasiEA
StaffordRS
2004 Promotion and prescribing of hormone therapy after report of harm by the Women's Health Initiative. JAMA 292 1983 1988
11. RavdinPM
CroninKA
HowladerN
BergCD
ChlebowskiRT
2007 The decrease in breast-cancer incidence in 2003 in the United States. N Engl J Med 356 1670 1674
12. ChlebowskiRT
KullerLH
PrenticeRL
StefanickML
MansonJE
2009 Breast cancer after use of estrogen plus progestin in postmenopausal women. N Engl J Med 360 573 587
13. ChlebowskiRT
AndersonGL
GassM
LaneDS
AragakiAK
2010 Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women. JAMA 304 1684 1692
14. StaffordRS
SaglamD
CausinoN
BlumenthalD
1997 Low rates of hormone replacement in visits to United States primary care physicians. Am J Obstet Gynecol 177 381 387
15. SaverBG
TaylorTR
WoodsNF
StevensNG
1997 Physician policies on the use of preventive hormone therapy. Am J Prev Med 13 358 365
16. BrettAS
CarneyPI
McKeownRE
2005 Brief report: Attitudes toward hormone therapy after the Women's Health Initiative: a comparison of internists and gynecologists. J Gen Intern Med 20 416 418
17. SpanglerL
ReedSD
NekhyludovL
GrothausLC
LaCroixAZ
2009 Provider attributes associated with hormone therapy prescribing frequency. Menopause 16 810 816
18. HershAL
StefanickML
StaffordRS
2004 National use of postmenopausal hormone therapy: Annual trends and response to recent evidence. JAMA 291 47 53
19. Fugh-BermanA
ScialliAR
2006 Gynecologists and estrogen: An affair of the heart. Perspect Biol Med 49 115 130
20. SingerN
2009 August 4 Medical papers by ghostwriters pushed therapy. The New York Times Available: http://www.nytimes.com/2009/08/05/health/research/05ghost.html. Accessed 4 Aug 2009
21. RossJS
HillKP
EgilmanDS
KrumholzHM
2008 Guest authorship and ghostwriting in publications related to rofecoxib. JAMA 299 1800 1812
22. SteinmanMA
BeroLA
ChrenM
LandefeldCS
2006 Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med 145 284 293
23. HealyD
CattelD
2003 Interface between authorship, industry, and science in the domain of therapeutics. Brit J Psych 183 22 27
24. Fugh-BermanA
MelnickD
2008 Off-label promotion, on-target sales. PLoS Med 5 e210 doi:10.1371/journal.pmed.0050210
25. FauberJ
RustS
2009 January 25 UW course for doctors pushed risky therapy. Milwaukee Journal Sentinel Available: http://www.jsonline.com/features/health/38283649.html. Accessed 5 February 2011
26. FauberJ
KissingerM
2009 August 15 UW linked to ghostwriting. Milwaukee Journal Sentinel Available: http://www.jsonline.com/features/health/53315032.html. Accessed 5 February 2011
27. Publication Program Drug Industry Document Archive. Available: http://dida.library.ucsf.edu/tid/kjb37b10. Accessed 20 November 2010
28. Publication Program A Proposal for Wyeth-Ayerst Pharmaceuticals - Council on Hormone Education, Scientific Update on Hormones and Postmenopausal Health. Available: http://dida.library.ucsf.edu/tid/iyb37b10. Accessed 20 November 2010
29. RandolphJJ
2008 Online kappa calculator. Available: http://justus.randolph.name/kappa. Accessed 26 August 2009
30. LexchinJ
BeroLA
DjulbegovicB
ClarkO
2003 Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ 326 1167 1170
31. JørgensenAW
HildenJ
GøtzschePC
2006 Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: Systematic review. BMJ 333 782
32. JørgensenAW
MaricKL
TendalB
FaurschouA
GøtzschePC
2008 Industry-supported meta-analyses compared with meta-analyses with non-profit or no support: differences in methodological quality and conclusions. BMC Med Res Methodol 8 60
33. CosgroveL
BursztajnHJ
KrimskyS
AnayaM
WalkerJ
2009 Conflicts of interest and disclosure in the American Psychiatric Association's Clinical Practice Guidelines. Psychother Psychosom 78 228 232
34. RoseJ
2008 Industry influence in the creation of pay-for-performance quality measures. Qual Manag Health Care 17 27 34
35. HemminkiE
2003 Opposition to unpopular research results: Finnish professional reactions to the WHI findings. Health Policy 69 283 291
36. PrenticeRL
ChlebowskiRT
StefanickML
MansonJE
PettingerM
2008 Estrogen plus progestin therapy and breast cancer in recently postmenopausal women. Am J Epidemiol 167 1207 1216
37. American College of Cardiology ACCEL: ACCF's Disclosure/conflict of interest policy. Available: http://stage.acc.org/accel_disclosures.htm. Accessed November 26, 2010
38. BushTM
BonomiAE
NekhlyudovL
LudmanEJ
ReedSD
2007 How the Women's Health Initiative (WHI) influenced physicians' practice and attitudes. J Gen Intern Med 22 1311 1316
39. StelfoxHT
ChuaG
O'RourkeK
DetskyAS
1998 Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 338 101 106
40. TatsioniA
SiontisGCM
IoannidisJPA
2010 Partisan perspectives in the medical literature: A study of high frequency editorialists favoring hormone replacement therapy. J Gen Int Med 25 914 919
41. MathesonA
2008 Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 3 355 382
42. GlinertLH
2005 TV commercials for prescription drugs: a discourse analytic perspective. Res Social Admin Pharm 1 158 184
43. [No authors listed] 2009 Self-plagiarism: Unintentional, harmless, or fraud? Lancet 374 664
44. PLoS Medicine 2009 Ghostwriting: The dirty little secret of medical publishing that just got bigger. Available: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000156. Accessed 12 February 2011
45. Fugh-BermanAJ
2010 The haunting of medical journals: How ghostwriting sold “HRT”. PLoS Med 7 e1000335 doi:10.1371/journal.pmed.1000335
46. Draft of Low-Dose Review Paper [With Annotations] DWRITE073011. Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/tid/qlc37b10. Accessed 26 November 2010
47. Low-dose Review Paper Submitted to Climacteric DWRITE73106. Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/tid/qnb37b10. Accessed 26 November 2010
48. Response Letter to Alastair MacLennan Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). DWRITE072945. Available: http://dida.library.ucsf.edu/tid/qib37b10. Accessed 26 November 2010
49. Draft of metabolic paperDELCA032-028548 Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/tid/czb37b10. Accessed 26 November 2010
50. Effects of Lower Doses of Conjugated Estrogens and Medroxyprogesterone Acetate on Plasma Lipids and Lipoproteins, Coagulation Factors, and Carbohydrate Metabolism Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). DELCA032-028549. Available: http://dida.library.ucsf.edu/tid/czc37b10. Accessed 26 November 2010
51. Inconsistency in Epidemiological Findings on Postmenopausal Hormone Therapy and Breast Cancer DWRITE078512. (Exh. 96 to Janas Depos.) Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/tid/rrb37b10. Accessed 26 November 2010
52. Re: Draft of Manuscript DWRITE078370. (Exh. 95 to Janas Depos.) Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/tid/rqc37b10. Accessed 26 November 2010
53. Janas Deposition: 483:1l–485:13 Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/pdf/skc37b10. Accessed 26 November 2010
54. Endometrial paper and action steps from last meeting DELCA031-019050 Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/search?query=DELCA031-019050&ct=1. Accessed 26 November 2010
55. Endometrial Effects of Lower Doses of Conjugated Equine Estrogens and Medroxyprogesterone Acetate DELCA031-019052. Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas). Available: http://dida.library.ucsf.edu/pdf/cvc37b10. Accessed 26 November 2010
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