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Jeffrey Dach
Bioidentical Hormones and GhostWriting Jeffrey Dach
Thu Dec 16, 2010 19:41
65.2.44.3

Bioidentical Hormones and Medical GhostWriting, the Latest Scandal by Jeffrey Dach MD

Link to this article:
http://jeffreydach.com/2010/07/12/bioidentical-hormones-and-medical-ghostwriting-by-jeffrey-dach-md.aspx


Why is My Doctor Opposed to Bioidentical Hormones?

Linda is 53, and suffering from menopausal symptoms of hot flashes, night sweats, insomnia and mood disturbance. While at the hair salon, a friend told her she needed hormone therapy, so she went on the internet to read up on it. Linda learned about the Womens's Health Initiative Study that showed synthetic hormones are unsafe, causing breast cancer and heart disease. Once she learned this information, she then felt confident her OB Gyne doctor would prescribe the safer bioidenticals for her. Next, she cheerfully made an appointment to see her OB Gyne doctor thinking he would gladly prescribe bioidentical hormones. To her dismay, Linda's doctor was not at all pleased when she raised the topic. Her doctor scowled and said, "those aren't any good", and besides, "there is no evidence that bioidentical hormones are any safer than synthetics". Linda ran out the door crying all the way home. A few days later, Linda was sitting in my office asking, "Why is my doctor opposed to bioidentical hormones?"

Above left image , Ghost stories May 1927 courtesy of wikimedia commons.

Your Doctor is Reading Ghost Written Articles Biased Against Bioidenticals

I explained to Linda that her doctor reads medical journals containing ghost written articles from the synthetic hormone industry, Wyeth and Pfizer. Ghost written means the real author is hidden, without a disclosure that the real author is a ghost writer hired by the pharmaceutical company. DesignWrite and PharmaWrite provide the medical writers for hire, who are then instructed to downplay the adverse effects of synthetic hormones, and raise doubts about bioidenticals. Medical ghostwriting is marketing, rather than science. As such, it is a form of plagiarism, scientific misconduct and fraud. The invited "author" is usually an academic professor in a university medical center serving as opinion leader who lends his name for the article.

Shocking Revelations from Drug Litigation, Medical Ghostwriting

8,000 women have filed court claims against Wyeth-Pfizer, claiming that their synthetic hormone pill, Prempro caused breast cancer. During the discovery process, internal company documents were made public revealing the extent of the medical ghost writing. About 44 articles in the women's health medical literature are ghost written by Wyeth in a marketing program to convince doctors to prescribe their synthetic hormones, and not to prescribe bioidenticals. These documents are publicly available in a document database .

Left Image: Ghost courtesy of wikimedia commons.

An Example of Medical Ghost Writing in the Women's Hormone Literature

Here is an example of biased pro-industry medical ghostwriting. The article is entitled, Bioidentical hormone therapy: a review of the evidence. by Michael Cirigliano, an Internist at the University of Pennsylvania School of Medicine, published in the Journal of Womens Health. (2007 Jun;16(5):600-31.) Michael Cirigliano is Associate Professor of Medicine at the U Penn Medical center.

At the very end of the article (page 625), you will find this notice:
ACKNOWLEDGMENTS - I received editorial assistance from Eugene R.Tombler, Ph.D., Florencia Schapiro, Ph.D., and Monica Ramchandani, Ph.D., of PharmaWrite,LLC..

Pharmawrite/Designwrite is the medical ghostwriting company paid by Wyeth to write the 44 articles on women's hormones. They are currently under investigation by Grassley's senate committee. Dr Cirigliano acknowledges three PHD medical ghost writers from Pharmawrite paid by an (unnamed) drug company to write a pro-synthetic hormone article biased against bioidentical hormones. The article is a review of the literature to determine if sufficient scientific evidence supports claims of greater efficacy and safety for bioidentical hormones compared to synthetic hormones". And the conclusion, you guessed it, "No scientific evidence to support this".

In case you were thinking this is OK, the University of Pennsylvania School of Medicine (Penn Medicine) has policies against plagiarism and it considers ghostwriting to be the equivalent of plagiarism. Plagiarism is a serious academic infraction, and a deviation from academic norms.

Lefrt Image :Ghost Stories 1931 courtesy of wikimedia commons.

Comparison with Non-Biased Review

For comparison, let's look at different review of the medical literature, this time not ghost written by the synthetic hormone industry. This review article is entitled,

The Bioidentical Hormone Debate: Are Bioidentical Hormones Safer or More Efficacious than Synthetic Hormone Replacement Therapy? by Kent Holtorf, MD. Postgraduate Medicine: Volume 121: No.1 January 2009.

The doctor's conclusion after reviewing the medical literature is: YES, they are. "Bioidentical hormones have lower risk of breast cancer and heart disease, and are more efficacious than synthetic counterparts. Until evidence is found to the contrary, bioidentical hormones remain the preferred method of HRT." Dr Holtorf cites 196 medical studies to support his conclusion.

You are probably wondering, how is it possible for two smart doctors to come to the exact opposite conclusion? Cirigliano says No they are not, and Holtorf says Yes they are.

The answer is simple, none of the medical studies that Holtorf cites are cited in Cirigliano's article. The two articles review the medical literature to answer the same question, yet they come up with two sets of totally different medical studies. Why is that? Remember we talked about selective sampling. Well, here it is again.

The ghost written Cirigliano article accepts only RCT studies as evidence. These are randomized controlled studies with a drug group and a placebo group. These are large studies funded by drug companies for FDA approval of a new drug. Since bioidentical hormones are not a new drug, they are natural substances that cannot be patented, drug companies will not spend money funding such a controlled trial.

Since there are no large RCT studies of bioidentical hormones, Holtorf cites other types of medical studies that are equally valid, such as observational studies like the French cohort study and others. Many of his cited studies are epidemiological studies which are not the gold standard, but are still published and accepted as medical evidence. Holtorf's article also includes basic science and animal studies.

There are no Randomized Controlled Trials (RCT) for bioidenticals because Bioidenticals are natural and cannot be patented. A drug company will NEVER spend the 500 million for a RCT for a drug that cannot be patent protected. In any event, with the information we have now, one could argue it would be unethical to do a randomized control study comparing progesterone to the progestins. The adverse effects of progestins are well known.

Medical Ghost Writing Should Be Banned

Medical ghost writing, as we have seen in the women's hormone literature, is a form of plagiarism, scientific misconduct and fraud. It is harmful to the public and should be banned.

Addendum

Take a look at this list of articles cited by Holtorf as evidence that synthetic hormones causes breast cancer. This list is what the drug companies don't want you to see. This is very convincing. See below:

7. de Lignières B. Effects of progestogens on the postmenopausal breast.
Climacteric. 2002;5(3):229–235.

8. Campagnoli C, Clavel-Chapelon F, Kaaks R, Peris C, Berrino F. Progestins
and progesterone in hormone replacement therapy and the risk
of breast cancer. J Steroid Biochem Mol Biol. 2005;96(2):95–108.

58 Fournier A, Berrino F, Riboli E, Avenel V, Clavel-Chapelon F. Breast
cancer risk in relation to different types of hormone replacement therapy
in the E3N-EPIC cohort. Int J Cancer. 2005;114:448–454.

71. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the
Women’s Health Initiative Investigators. Risks and benefits of estrogen
plus progestin in healthy postmenopausal women: principal results
From the Women’s Health Initiative randomized controlled trial. JAMA.
2002;288(3):321–333.

72. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated
equine estrogen in postmenopausal women with hysterectomy:
the Women’s Health Initiative randomized controlled trial. JAMA.
2004;291(14):1701–1712.

73. Chlebowski RT, Hendrix SL, Langer RD, et al. Influence of estrogen
plus progestin on breast cancer and mammography in healthy postmenopausal
women: the Women’s Health Initiative Randomized Trial.
JAMA. 2003;289(24):3243–3253.

74. Porch JV, Lee IM, Cook NR, Rexrode KM, Burin JE. Estrogen-progestin
replacement therapy and breast cancer risk: the Women’s Health Study
(United States). Cancer Causes Control. 2002;13(9):847–854.

75. Lee SA, Ross RK, Pike MC. An overview of menopausal oestrogenprogestin
hormone therapy and breast cancer risk. Br J Cancer.
2005;92(11):2049–2058.

76. Ewertz M, Mellemkjaer L, Poulsen AH, et al. Hormone use for
menopausal symptoms and risk of breast cancer. A Danish cohort study.
Br J Cancer. 2005;92(7):1293–1297.

77. Newcomb PA, Titus-Ernstoff L, Egan KM, et al. Postmenopausal
estrogen and progestin use in relation to breast cancer risk. Cancer
Epid Bio Prev. 2002;11(7):593–600.

Stahlberg C, Pedersen AT, Lynge E, et al. Increased risk of breast
cancer following different regimens of hormone replacement therapy
frequently used in Europe. Int J Cancer. 2004;109(5):721–727.

79. Li CI. Postmenopausal hormone therapy and the risk of breast cancer:
the view of an epidemiologist. Maturitas. 2004;49(1):44–50.

80. Magnusson C, Baron JA, Correia N, Bergström R, Adami HO, Persson
I. Breast-cancer risk following long-term oestrogen- and oestrogenprogestin-
replacement therapy. Int J Cancer. 1999;81(3):339–344.

81. Schairer C, Lubin J, Troisi R, Sturgeon S, Brinton L, Hoover R.
Estrogen-progestin replacement and risk of breast cancer. JAMA.
2000;284(6):691–694.

82. Ross RK, Paganini-Hill A, Wan PC, Pike MC. Effect of hormone
replacement therapy on breast cancer risk: estrogen versus estrogen
plus progestin. J Natl Cancer Inst. 2000;92(4):328–332.

83. Warren MP. A comparative review of the risks and benefits of
hormone replacement therapy regimens. Am J Obstet Gynecol.
2004;190(4):1141–1167.

84. Weiss LK, Burkman RT, Cushing-Haugen KL, et al. Hormone replacement
therapy regimens and breast cancer risk(1). Obstet Gynecol.
2002;100(6):1148–1158.

85. Li CI, Malone KE, Porter PL, et al. Relationship between long durations
and different regimens of hormone therapy and risk of breast cancer.
JAMA. 2003;289(24):3254–3263.
86. Beral V; Million Women Study Collaborators. Breast cancer and
hormone-replacement therapy in the Million Women Study. Lancet.
2003;362(9382):419–427.

87. Kirsh V, Kreiger N. Estrogen and estrogen–progestin replacement
therapy and risk of postmenopausal breast cancer in Canada. Cancer
Causes Control. 2002;13(6):583–590.

88. Breast cancer and hormone replacement therapy: collaborative reanalysis
of data from 51 epidemiological studies of 52,705 women with breast
cancer and 108,411 women without breast cancer. Collaborative Group
on Hormonal Factors in Breast Cancer. Lancet. 1997;350(9084):1047–
1059.

89. Schairer C, Lubin J, Troisi R, Sturgeon S, Brinton L, Hoover R. Menopausal
estrogen and estrogen-progestin replacement therapy and breast
cancer risk. JAMA. 2000;283(4):485–491.

90. Colditz G, Rosner B. Use of estrogen plus progestin is associated with
greater increase in breast cancer risk than estrogen alone. Am J Epidemiol.
1998;147:S45.

91. Persson I, Weiderpass E, Bergkvist L, Bergström R, Schairer C. Risks
of breast and endometrial cancer after estrogen and estrogen-progestin
replacement. Cancer Causes Control. 1999;10(4):253–260.

92. Chen CL, Weiss NS, Newcomb P, Barlow W, White E. Hormone
replacement therapy in relation to breast cancer. JAMA.
2002;287(6):734–741.

93. Pike MC, Ross RK. Progestins and menopause: epidemiological studies
of risks of endometrial and breast cancer. Steroids. 2000;65(10–11-
):659–664.

94. Santen RJ, Pinkerton J, McCartney C, Petroni GR. Risk of breast cancer
with progestins in combination with estrogen as hormone replacement
therapy. J Clin Endocrinol Metab. 2001;86(1):16–23.

95. Stahlberg C, Pederson AT, Lynge E, Ottesen B. Hormone replacement
therapy and risk of breast cancer: the role of progestins. Acta Obstet
Gynecol Scand. 2003;82(7):335–344.

96. Olsson HL, Ingvar C, Bladström A. Hormone replacement therapy
containing progestins and given continuously increases breast carcinoma
risk in Sweden. Cancer. 2003;97(6):1387–1392.

97. Colditz GA, Hankinson SE, Hunter DJ, et al. The use of estrogens and
progestins and the risk of breast cancer in postmenopausal women. N
Engl J Med. 1995;332(24):1589–1593.

98. Colditz GA, Rosner B. Cumulative risk of breast cancer to age 70 years
according to risk factor status: data from the Nurses’ Health Study. Am
J Epidemiol. 2000;152(10):950–964.

None of these studies are mentioned in the ghost written articles from Wyeth, and these are the articles your doctor reads. No wonder your doctor is opposed to bioidentical hormones.

Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood Fl 33021
954-983-1443
www.jeffreydach.com
www.drdach.com
www.naturalmedicine101.com
www.truemedmd.com


Links and References:

http://www.postgradmed.com/index.php?article=1949
Postgraduate Medicine: Volume 121: No.1 January 2009.
The Bioidentical Hormone Debate:Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?Kent Holtorf, MD Conclusion: Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animalderived counterparts. Until evidence is found to the contrary, bioidentical hormones remain the preferred method of HRT. Further randomized controlled trials are needed to delineate these differences more clearly.

http://www.iacprx.org/site/DocServer/HoltorfStudy_Jan09_PostgraduateMedicine.pdf?docID=5841

http://online.wsj.com/article/SB123717056802137143.html
MARCH 16, 2009 The Truth About Hormone Therapy Wall Street Journal
By ERIKA SCHWARTZ , KENT HOLTORF , and DAVID BROWNSTEIN, Mainstream medicine has been given a wake-up call on a matter critical to the health of 65 million women in the U.S. At issue are the options for treatment of menopause

http://www.ncbi.nlm.nih.gov/pubmed/18928825
Prim Care. 2008 Dec;35(4):669-705. Hormones in wellness and disease prevention: common practices, current state of the evidence, and questions for the future.
Schwartz ET, Holtorf K.

http://www.jpands.org/vol13no2/hotze.pdf
Point/Counterpoint:The Case for Bioidentical Hormones by Steven F. Hotze, M.D.
Donald P. Ellsworth, M.D. Journal of American Physicians and Surgeons Volume 13 Number 2 Summer 2008 p43.

http://www.ncbi.nlm.nih.gov/pubmed/18775609
Could transdermal estradiol + progesterone be a safer postmenopausal HRT? A review.
L'hermite M, Simoncini T, Fuller S, Genazzani AR. Maturitas. 2008 Jul-Aug;60(3-4):185-201. Epub 2008 Sep 5. Department of Gynecology and Obstetrics, Université Libre de Bruxelles, Bruxelles, Belgium.

http://www.thorne.com/altmedrev/.fulltext/11/3/208.pdf
A Comprehensive Review of the Safety and Efficacy of Bioidentical Hormones for the Management of Menopause and Related Health Risks Deborah Moskowitz, ND Altern Med Rev 2006;11(3):208-223

http://www.ncbi.nlm.nih.gov/pubmed/17107222
Treat Endocrinol. 2006;5(6):367-374.
Is Bio-Identical Hormone Replacement Therapy Safer than Traditional Hormone Replacement Therapy?: A Critical Appraisal of Cardiovascular Risks in Menopausal Women.
Curcio JJ, Wollner DA, Schmidt JW, Kim LS. Women’s Integrative Medicine Department, Southwest College of Naturopathic Medicine, Tempe, Arizona, USA.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2211383/
Breast Cancer Res Treat. 2008 January; 107(1): 103–111.
Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study
Agnès Fournier,1 Franco Berrino,2 and Françoise Clavel-Chapelon1*

anti-bioidentical ghost written

MICHAEL CIRIGLIANO J Womens Health (Larchmt). 2007 Jun;16(5):600-31.
Bioidentical hormone therapy: a review of the evidence.
Cirigliano M.University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104,
http://www.solaltech.com/doctors/3/Bioidentical%20Hormone%20Therapy--%20Cirigliano.pdf

ACKNOWLEDGMENTS I received editorial assistance from Eugene R.Tombler, Ph.D., Florencia Schapiro, Ph.D., and Monica Ramchandani, Ph.D., of PharmaWrite,LLC.

Grssley Senate Investigation

http://grassley.senate.gov/about/upload/Senator-Grassley-Report.pdf

http://graphics8.nytimes.com/2010/06/25/business/SenatorGrassleyReport.pdf

Ghostwriting in Medical Literature Minority Staff Report 111th Congress United States Senate Committee on Finance Sen. Charles E. Grassley, Ranking Member June 24, 2010

products and then invited academic researchers to sign on as the primary authors. The
documents also revealed information about the process. In one email dated March 24, 1999,
DesignWrite’s Vice President for Scientific Affairs described the company’s role to Wyeth:

The first step is to choose the target journal best suited to the manuscript’s
content, thus avoiding the possibility of manuscript rejection. We will then
analyze the data and write the manuscript, recruit a suitable well-recognized
expert to lend his/her name as author of the document, and secure his/her approval
of its content. After the client has reviewed and released the manuscript for
submission, DesignWrite will see it through the necessary production stagescreating
camera-ready figures and tables and the text according to the journal
guidelines-and submit the package…to the appropriate journal editor. Any
revisions requested by the journal will be handled by DesignWrite in conjunction
with the client and the author. Should the journal reject the manuscript,
DesignWrite will restyle it for submission to another journal within 10 working
days. [Emphasis added] See Attachment 1

According to Wyeth, 44 review articles relating to the Premarin products were authored by outside academic experts with “publication support” from DesignWrite. DesignWrite’s documents show that the company “initiated a comprehensive, peer-reviewed publication program in support of the PREMARIN Family of Products” in 1997.

The medical articles did not disclose that Wyeth had initiated and paid DesignWrite for the
development of the manuscripts and that the medical writers were hired and compensated by DesignWrite. John Eden, “Progestins and Breast Cancer,” Am J Obstet Gynecol, 2003; 188(5): 1123-1131; Lila E. Nachtigall, “Sex Hormone-Binding Globulin and Breast Cancer Risk,” Prim Care Update OB/GYNs, 1999; 6(3): 39-45; Trudy L. Bush, Maura Whiteman, and Jodi A. Flaws, “Hormone Replacement Therapy and B reast Cancer: A Qualitative Review,” Obstet Gynecol, 2001; 98(3): 498-508.

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000230

Ghostwriting at Elite Academic Medical Centers in the United States,”7
Jeffrey R. Lacasse and Jonathan Leo, “Ghostwriting at Elite Academic Medical Centers in the United States,” PLoS Med, 2010; 7(2): 1-4.

Medical ghostwriting is a particularly troubling form of manipulation. When they are appropriately acknowledged for their involvement, medical writers paid by drug companies…may have a legitimate role in helping shape papers for publication. However, when the medical writers’ involvement is hidden they become ghostwriters, and hence they are unaccountable for their work. The fact that ghostwriters are paid for by drug companies, and that their role is by definition hidden, suggests that it is likely that they will write about a company’s products in a biased way….When ghostwriters are used, readers are unaware that the company was ever involved in shaping the article’s contents. Instead, the published article bears only the names of the academic
physicians or scientists, who are often highly renowned and trusted in their fields. By keeping the company’s role in the article hidden, the article has greater credibility in the eyes of the medical community, and thus greater opportunity for influencing the prescribing behavior of physicians.8

Declaration of Virginia Barbour in support of the Public Library of Science’s Motion to Intervene and Motion for Access to Discovery Materials, In re Prempro Products Liability Litigation (D. Ark. 2009), available at http://www.plosmedicine.org/static/ghostwritingDeclaration.pdf.

“Editorial assistance” may suggest to the reader and journal editors that there was
involvement of a third party medical writer, hired by a pharmaceutical company through a
medical educational, communications or marketing company, to develop publications in support
of the pharmaceutical company’s products. When professional writing staff assist an author in interpreting data and/or producing a publication, the author should recognize their contributions
appropriately in the resulting publication. For xample, the acknowledgment/disclosure statement for editorial support would be: “Editorial/medical writing support was provided by at and was funded by Pfizer Inc.”

http://www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship.jsp
Authors must also acknowledge individuals who provide editorial support and disclose the funding source. For Pfizer-sponsored studies the fact that the study was funded by Pfizer must be disclosed.

Six of the medical schools have policies that explicitly prohibit ghostwriting—Columbia,
Johns Hopkins Medicine, Stanford Medicine, UCSF, UW Medicine, and Washington
University.

University of Pennsylvania School of Medicine (Penn Medicine) does not use the term “ghostwriting” in its authorship policies, but stated that it has policies against plagiarism and it considers ghostwriting to be the equivalent of plagiarism.

all of the medical schools reported that they do not allow or condone
ghostwriting. For example, some referred to the practice as “unacceptable,” a “violation of
university policy,” “inconsistent with principles of sound research and scholarship,” and
“contrary to the values and principles of academic medicine.”

the Annals of Internal Medicine,
the Archives of Internal Medicine, and JAMA also require the public disclosure and
acknowledgment of individuals who contribute to a publication, such as medical writers,
industry employees, and/or other contributing non-authors. The AMA Manual of Style
also notes that JAMA “discloses the affiliation and funding of individuals who contribute
to manuscripts but who are not authors.” In addition, it notes that such disclosure is
supported by the American Medical Writers Association and the European Medical
Writers Association “as it is more helpful to editors, reviewers, and readers than are
vague statements about writing or editorial assistance that gives no indication about
financial relationships.”

Drs. Lacasse and Leo stated that when academic medical centers do not prohibit their
faculty from participating in ghostwriting, the centers:
enable the pharmaceutical company to covertly shape the medical literature in
favor of commercial interests.

The Institute of Medicine (IOM) also recommended that academic medical centers adopt
policies prohibiting ghostwriting.It raised concern about the practice, stating:
Such arrangements (which are essentially gifts) send the wrong message about the
values of intellectual independence, professional ethics, accountability, and
evidence-based medicine. In the context of research, they raise questions about
the objectivity of research reports that other researchers as well as practitioners
and developers of practice guidelines rely on.23
__________________________________

Bio-Ethics

http://www3.interscience.wiley.com/cgi-bin/fulltext/122204938/PDFSTART
Bioethics ISSN 0269-9702 (print); 1467-8519 (online) Volume 24 Number 6 2010 pp 267–272
PROFITS AND PLAGIARISM: THE CASE OF MEDICAL GHOSTWRITING TOBENNA D. ANEKWE

ABSTRACT This paper focuses on medical ghostwriting in the United States. I argue
that medical ghostwriting often involves plagiarism and, in those cases, can
be treated as an act of research misconduct by both the federal government
and research institutions. I also propose several anti-ghostwriting measures,
including: 1) journals should implement guarantor policies so that
researchers may be better held accountable for their work; 2) research
institutions and the federal government should explicitly prohibit medical
ghostwriting and outline appropriate penalties; and 3) a publicly available
database should be created to record researchers’ ethics violations.

Medical ghostwriting is a serious breach of medical ethics and a violation of the standard of excellence that readers have come to expect from journals. This paper argues that honorary authorship is plagiarism and thus subject to federal and academic policies on research misconduct

Industry ghostwriting in medical journals violates norms of transparency and proper conduct in science. University policies are quite vocal when it comes to plagiarism. Plagiarism occurs when an author takes credit for writing or ideas that have come from someone else. University students who are found guilty of plagiarism may face academic probation, suspension, or even outright
expulsion in cases of extreme forms or repeated acts of plagiarism. Faculty researchers are not exempt either. Take Brown University for example, which has policies on plagiarism and other types of research misconduct. At Brown, research faculty and department administrators
found guilty of research misconduct may face probation, suspension, or termination of employment.13 For example, industry ghostwriting could be codified as a punishable federal offense, resulting in fines. Similar legal consequences already exist for pharmaceutical companies that commit the federal offense of promoting drugs for off-label use because honorary authorship is a form of plagiarism, it would also fall under the larger rubric of research misconduct.

the whole point of industry ghostwriting is to hide the involvement of the industry.

http://www3.interscience.wiley.com/cgi-bin/fulltext/122204937/PDFSTART

Bioethics ISSN 0269-9702 (print); 1467-8519 (online) Volume 24 Number 6 2010 pp 273–283
PUBLICATION ETHICS AND THE GHOST MANAGEMENT OF MEDICAL PUBLICATION by
SERGIO SISMONDO AND MATHIEU DOUCET

Such discussions address violations of specifically scientific or academic norms, such as those
dealing with plagiarism, fabrication of data, duplicate publication,2 and, in particular, authorship.

Scientific misconduct in publication, from plagiarism and fabrication to duplicate publication and questionable authorship practices, Pharmaceutical company funding has been repeatedly shown to affect published results strongly.36 If ghost-managed research is primarily undertaken in
the interests of marketing, then this suggests that significant quantities of medical research involving human subjects is performed not primarily to increase knowledge for broad human benefit, but to disseminate results in the service of profits. Since the risk of medical research on
human subjects is justified by the prospect of health benefits from increased knowledge, as required by the Nuremberg Code, the Declaration of Helsinki, and subsequent guidelines, much of the scientific research currently published in medical journals is ethically problematic. This is a major problem for research ethics.

It means that apparently ethically sound research, carried out with patient consent, approved by ethics boards, and appearing to respect the principle of equipoise – though given the way funding biases results, equipoise is typically violated40 – is nevertheless deeply suspect. Research
carried out primarily for marketing purposes places patients at risk for the sake of private profits, not public knowledge. Pharmaceutical companies and their agents are not the only parties to blame for this violation of research ethics: both the academic researchers who participate in such research or allow it to be published under their names, and journal editors who publish it are also
deeply implicated in unjustifiably placing human research subjects at risk. We have argued that authors and journal editors are complicit in unjustifiably putting trial participants at risk.
On its own, this is bad enough, and would be a serious breach of research ethics even if it rarely, or even never, led to significant adverse health effects. But such practices
do have serious effects on health. Moreover, these effects are not confined to trial participants but potentially extend into the general public.

In such cases, patients are not merely put at risk by the way ghost management uses medical research for marketing purposes: they are actually harmed. Not only does ghost-managed research put Studies that display a significant pro-sponsor bias play an important role in the drug approval process, in clinical practice guidelines, in physicians’ prescribing practices,
and even, in some cases, in patients’ beliefs about which treatments they should pursue. Sometime, this means that drugs that should be neither approved nor prescribed end up in wide use, the recent Vioxx controversy being only one prominent example. In such cases, patients are not merely put at risk by the way ghost management uses medical research for marketing purposes: they are actually harmed. Not only does ghost-managed research put
trial participants at risk, it threatens the health of millions of patients who take drugs that might otherwise not be prescribed. It may, through disease-mongering, alter physicians’
and potential patients’ conceptions of health and disease, leading to more perceptions of disease and more prescriptions.59 Ghost management therefore has serious implications for health, both for trial participants and for the public at large.

http://www3.interscience.wiley.com/cgi-bin/fulltext/123442700/PDFSTART
Phrases such as ‘ghost authorship’ and ‘honorary authorship’ suggest that the ethical problem is one of deception: hiding the involvement of the actual writer of a scientific article. Yet the problem of ghostwriting would not disappear if the contributions of medical writers were uniformly acknowledged in scientific publications, or even if they were listed as authors. Academic opinion
leaders would still get credit for authoring or co-authoring articles to which they did not really contribute in any meaningful way, and pharmaceutical companies would still spin their publications to suit their marketing aims. The only difference would be that the ghostwriters and medical communications companies might become somewhat easier to identify.

When a pharmaceutical company recruits an academic researcher to become the author of a ghosted article, it takes the perception that academic researchers are people who work in the public interest and uses it to market a product.

http://publicationethics.org/blogs/
ghostauthors-ghost-management-and-manipulation-medical-research

Ghostauthors, ghost management and the manipulation of medical research
There are three articles in the June issue of Bioethics on different aspects of ghostwriting.

The first article, by Tobenna D Anekwe, “Profits and plagiarism: the case of medical ghostwriting” argues that “medical ghostwriting often involves plagiarism and, in those cases, can be treated as an act of research misconduct” and suggests measures to counter ghostwriting.

The second article, by Sergio Sismondo and Mathieu Doucet, “Publication ethics and the ghost management of medical publication" discusses the wider issue of management of the whole publication process, showing how “pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles."

The final article, by Carl Elliott and Amy Snow Landa, "What’s wrong with ghostwriting?" concludes that ghost authorship and ghost management are part of a much larger problem, “the manipulation of medical research for marketing purposes.”
Posted by Virginia Barbour, COPE Secretary on June 22nd 2010

http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000230
Ghostwriting at Elite Academic Medical Centers in the United States. PLoS Medicine article by Jeffrey R. Lacasse and Jonathan Leo describes the practice of "medical ghostwriting," The authors explain that by allowing such ghostwriting, academic medical centers enable the pharmaceutical industry to covertly shape the medical literature in favor of commercial interests. Even beyond frank misrepresentation of data, commercially driven ghostwritten articles shape the medical literature in subtler but important ways, affecting how health conditions and treatments are perceived by clinicians. The ability of industry to exercise clandestine influence over the peer-reviewed medical literature is thus a serious threat to public health. In 2009, the Institute of Medicine recommended that US-based academic medical centers enact policies that prohibit ghostwriting by their faculties

The practice of ghostwriting explicitly violates the usual norms of academia. A recent New York Times article characterizes medical ghostwriting as “an academic crime akin to plagiarism.
For instance, ghostwriting may be characterized as a form of plagiarism [14], and to our knowledge, all academic institutions consider plagiarism to be a form of academic misconduct.

Administrators should carefully monitor the medical literature for clues of ghostwriting, such as an acknowledgment of a medical writer's assistance in a peer-reviewed journal article. When a medical writer is thanked, this will be taken to mean that they do not qualify for authorship, much in the way that a copyeditor does not receive a byline credit. At present, such acknowledgments are suspected to mean that the medical writer actually ghostwrote the paper

Medical ghostwriting is a threat to public health which currently takes place only due to the cooperation of researchers employed at academic medical centers. Although there is growing awareness of the danger posed by medical ghostwriting, we find that few academic medical centers have public policies which prohibit this behavior, and many of the existing policies are ambiguous or ill-defined. We have proposed an unambiguous policy which defines participating in medical ghostwriting as academic misconduct akin to plagiarism or falsifying data. By adopting and enforcing this policy, academic medical centers would adhere to the norms of science followed across the rest of the University, and would no longer facilitate clandestine industry influence over the peer-reviewed scientific literature. By prohibiting medical ghostwriting, academic medical centers have a rare opportunity- to significantly reduce a major threat to public health with the stroke of a pen.

http://www.nytimes.com/2009/08/19/health/research/19ethics.html?pagewanted=2

One of the authors discussed in DesignWrite documents is Dr. Michelle P. Warren, a professor of obstetrics and gynecology at Columbia. Her article was published in The American Journal of Obstetrics and Gynecology in 2004, when women feared that Wyeth’s brand of hormone drugs could be causing particular problems. The thesis of the article was that no one hormone therapy was safer than another.

The published article acknowledged help from four people. But it did not disclose that DesignWrite employed two of those people and the other two worked at Wyeth. Court documents show DesignWrite sent a prepublication copy to Wyeth for vetting and charged Wyeth $25,000 for the article, information not disclosed in the paper.

In a phone interview, Dr. Warren said the article was intended to clear up confusion over the risks of hormone drugs. She said she worked on the project in phone conversations and in meetings — contributions not reflected in the court documents, she added. She said that it was a mistake not to have disclosed the writers’ payment and affiliations in the acknowledgment; articles published today involve more detailed disclosures, she said.

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(American Family Physician) does not accept articles which have been authored or co-authored by pharma employees or supported by pharma dollars (ie, an "unrestricted grant" to write the article, or ghostwriting).

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http://www.scientificamerican.com/article.cfm?id=ghostwriter-science-industry
February 4, 2010 Ghostbusters: Authors of a new study propose a strict ban on medical ghostwriting. A scientist who takes credit as an author on an article secretly written by a pharmaceutical company should face punishment like any other plagiarist. Lacasse and Leo even recommend that scientists who have participated in ghostwriting in the past should confess, and that their ghostwritten papers be reevaluated and even retracted if appropriate.

While NIH policy does not use the term "ghostwriting," federal regulations on research misconduct such as plagiarism and fabrication could be applicable to ghostwriting, according to an NIH spokesperson.

In a recent interview on C–SPAN's "Newsmakers" program, NIH Director Francis Collins announced that the agency would issue a "proposed rule" early this year that will require pharmaceutical companies to publicly disclose financial relationships with NIH-funded scientists. "I was shocked by that revelation—that people would allow their names to be used on articles they did not write, that were written for them, particularly by companies that have something to gain by the way the data is presented…. If we want to have the integrity of science preserved, that's not the way to do it," Collins said in the December 21 interview. Lacasse says most nonmedical academics are astonished that ghostwriting occurs. "Try explaining to a history prof that on the other side of campus a prof is getting credit for work he didn't do!"

http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=326
How Great Researchers Get By-lines, Get Paid, and Get Medicine in Trouble
Medicine and Business Kate Jirik, 12/28/2006
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http://www.ama-assn.org/public/peer/7_15_98/jpv80004.htm
Authorship
Prevalence of Articles With Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals
(JAMA. 1998;280:222-224)
Annette Flanagin, RN, MA; Lisa A. Carey, PhD; Phil B. Fontanarosa, MD; Stephanie G. Phillips, MS, PhD; Brian P. Pace, MA; George D. Lundberg, MD; Drummond Rennie, MD
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http://www.nytimes.com/2008/12/12/business/13wyeth.html?_r=1&scp=2&sq=wyeth&st=cse
Drug Maker Said to Pay Ghostwriters for Journal Articles By DUFF WILSON December 12, 2008
The May 2003 article supporting Prempro was signed by Dr. John Eden, an associate professor at the University of New South Wales and director of the Sydney Menopause Center in Australia. Wyeth executives suggested that Dr. Eden write such a paper in 2000, according to the documents, and had the outline and draft manuscript written for him. The Archives of Internal Medicine rejected the paper before it was published in The American Journal of Obstetrics and Gynecology — with no mention of Wyeth or DesignWrite connections.

http://www.nytimes.com/2009/08/05/health/research/05ghost.html?_r=1&ref=health
Medical Papers by Ghostwriters Pushed Therapy August 4, 2009
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.

http://www.nytimes.com/2009/08/19/health/research/19ethics.html?_r=4&hp=&pagewanted=all
Senator Moves to Block Medical Ghostwriting By NATASHA SINGER August 18, 2009

http://www.nytimes.com/2009/09/11/business/11ghost.html
Ghostwriting Is Called Rife in Medical Journals By DUFF WILSON and NATASHA SINGER
Published: September 10, 2009

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2876906/
Indian J Anaesth. 2010 Jan–Feb; 54(1): 2–4.
Transgression in scientific communication
PF KoturEditor, SAARC Journal of Anaesthesia, Former Editor, Indian Journal of Anaesthesia, Sr.Prof. of Anaesthesiology, J.N. Medical College, Belgaum, Karnataka, India. E-mail:

Editors' bodies such as the ICMJE expressly define criteria for authorship in biomedical publications,[8] and the World Association of Medical Editors (WAME) developed a specific policy on ghostwriting[12] initiated by commercial companies that calls the practice dishonest, unacceptable, and sanctionable. Hence, journal polices should also include enforceable sanctions. For example, if nothing is declared on submission but inappropriate involvement of a medical writer subsequently comes to light, any papers where this breach is substantiated should be immediately retracted and those authors found to have not declared such interest should be banned from any subsequent publication in the journal and their misconduct should be reported to their institutions. Also, institutions whose academics are shown to be involved should be investigated as a matter of urgency.[13]

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http://www.cmaj.ca/earlyreleases/9sept09_ghostwriting.dtl
Roger Collier, CMAJ September 9, 2009 Prevalence of ghostwriting spurs calls for transparency
Between 50% and 100% of articles on drugs that appear in journals are ghostwritten, says British psychiatrist Dr. David Healy. It’s no secret that the names at the top of articles published in medical journals aren’t always a good indication of who actually wrote them. What may be surprising to many, though, is just how prevalent ghostwriting appears to have become.

Recently unveiled court documents, for example, show that ghostwriters, paid by the pharmaceutical company Wyeth, produced 26 papers supporting hormone replacement therapy. The documents were obtained by lawyers representing 8400 women who are suing Wyeth for harm they say resulted from the company’s hormone drugs. Listed as sole author on one of the papers was Dr. Barbara Sherwin, a psychology professor at McGill University in Montréal, Quebec. Yet, she actually wrote only portions of the article. The rest was prepared by DesignWrite, a ghostwriting firm hired by Wyeth.

The articles, which appeared in 18 medical journals between 1998 and 2005, detailed the benefits of the therapy, while minimizing its risks. In 2001, Wyeth’s hormone drugs earned sales of nearly US$2 billion. None of that shocked long-time critics of ghostwriting. “Somewhere between 50% and 100% of articles on drugs that appear in journals are ghostwritten,” says Dr. David Healy, a psychiatrist at the University of Cardiff in Wales, United Kingdom, and a critic of the drug industry's influence on physicians’ drug prescribing habits.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2219716/?tool=pmcentrez
J Gen Intern Med. 2007 July; 22(7): 1030–1034.
Published online 2007 March 7. doi: 10.1007/s11606-007-0141-4. PMCID: PMC2219716
Bioidentical Hormones for Menopausal Hormone Therapy: Variation on a Theme
Adriane Fugh-Berman, MD and Jenna Bythrow, MS candidate

Article co-authored by pharm sales rep.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2219716/?tool=pmcentrez

This work was partially supported by a grant from the Attorney General Prescriber and Consumer Education Grant Program. The authors received no funding for this report.Conflict of Interest Dr. Fugh-Berman has provided expert testimony on the plaintiff’s side in litigation regarding Prempro® (Wyeth). J. Bythrow is currently employed as a pharmaceutical sales representative with Eli Lilly.

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MD author lists address as Novo-Nordisc drug company. Employed by Novo Nordisk as of JAn 2005. Maida Taylor, M.D., MPH as clinical director of medical affairs in women's health products,

http://www.sciencedirect.com/science?
_ob=ArticleURL&_udi=B7GWD-4H6P82T-5&_user=10&_coverDate=10%2F31%2F2005&_rdoc=1&_fmt=high&_orig=search&_
sort=d&_docanchor=&view=c&_rerunOrigin=scholar.google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=a26db5497d1bf393059468013a1311a9#aff1
“Bioidentical” estrogens: Hope or hype? Maida Taylor MD, MPHa, , , Clinical Director
Women's Health, Clinical Research & Medical Affairs—Endocrinology, Novo Nordisk Inc.
100 College Road West, Princeton, NJ 08540

Maida Taylor, MD, is an associate clinical professor in the Department of Obstetrics and Gynecology and Reproductive Sciences at the University of California at San Francisco. Dr. Taylor has written many original research papers and articles on herbal medicine, and is an author of the American College of Obstetrics and Gynecology Guidelines on the "Use of Botanicals for the Management of Menopausal Symptoms."

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Ghost written according to NYT article John Eden

http://www.ncbi.nlm.nih.gov/pubmed/12748456
Am J Obstet Gynecol. 2003 May;188(5):1123-31.
Progestins and breast cancer. Eden J.
Royal Hospital for Women, University of New South Wales, Sydney, NSW, Australia.

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http://onlinejournal.com/artman/publish/article_5609.shtml
http://alethonews.wordpress.com/2010/02/23/pfizers-ghostwritten-journal-articles-are-still-standing-still-bogus/
Pfizer’s ghostwritten journal articles are still standing, still bogus
By Martha Rosenberg | Online Journal | February 23, 2010

“Is there an association between hormone replacement therapy and breast cancer?” asks an unretracted article in the Journal of Women’s Health, 1998 Dec;7(10):1231-46 -- a question a fourth grader could answer. The “author,” William T. Creasman, MD, neither wrote nor initiated the article but was suggested by Jeff Solomon of Wyeth, according to documents posted on the University of California, San Francisco’s Drug Industry Document Archive (Dida).
written by an operative of DesignWrite, Wyeth’s marketing firm, named Karen Mittleman.
Creasman-

http://www.hrt-legal.com/news/2010/02/09/ghostwritten-medical-journal-articles-about-hrt-should-be-retracted/ Ghostwritten medical journal articles about HRT should be retracted
February 9th, 2010 by Jennifer Walker-Journey

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Lawsuit diocuments reveals articles were ghostwritten mentioned in Martha Rosenberg

http://dida.library.ucsf.edu/documents.jsp
The Drug Industry Document Archive (DIDA) contains drug company documents and external resources about drug industry clinical trials, publication of results, pricing, marketing, relations with physicians and involvement in continuing medical education. A majority of the documents in DIDA were acquired as a result of lawsuits against some of the major pharmaceutical companies.

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