Chapter 11. Bioidentical Hormones and Medical Ghost Writing, the Latest Scandal

Chapter 11.

Bioidentical Hormones

and Medical Ghost Writing,

the Latest Scandal 

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 Women’s Health Initiative Study that showed synthetic hormones are unsafe, causing breast cancer and heart disease. Once she learned this information, she felt confident her OB Gyne doctor would prescribe the safer bioidentical hormones.  She cheerfully called the office to make 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?"

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 makers, Wyeth and Pfizer. Ghost written is a term which means the real author is not the doctor listed at the top of the article.  The real author of the article is a ghost writer hired by the pharmaceutical company.   The two companies, DesignWrite and PharmaWrite provide the medical writers for hire, with instructions to downplay the adverse effects of synthetic hormones, and raise doubts about bioidentical hormones.  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 to 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 bioidentical hormones. These documents are publicly available in a document database.

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 Women’s Health. (2007 Jun;16(5):600-31.  (10)  Michael Cirigliano is Associate Professor of Medicine at the University of Pennsylvania Medical center.  At the very end of the article (page 625), you will find this acknowledgement written by Dr. Cirigliano:  

Pharmawrite, also called Designwrite, is the medical ghostwriting company paid by Wyeth to ghostwrite medical articles on women's hormones. They have been under investigation by Grassley's senate committee for writing about 44 such articles. (11)(12)  Dr. Cirigliano acknowledges three PHD medical ghost writers from Pharmawrite.  I would assume an unnamed drug company paid these three PhD’s from Pharmawrite for a pro-synthetic hormone article biased against bioidentical hormones.  The name of the drug company that hired Designwrite is not disclosed.   I leave that to your own investigation. The resulting medical article is a literature review to establish if sufficient scientific evidence supports the claim that bioidentical hormones are safer and more effective than chemically altered synthetic hormones.   And as you could have guessed, the author’s conclusion is:  "There is No Scientific Evidence to support this (claim)”. (Quote from Dr. Cirigliano’s article.)

In case you were thinking this is OK, the University Of Pennsylvania School Of Medicine (Penn Medicine) has policies against plagiarism, and considers ghostwriting to be the equivalent of plagiarism.  Plagiarism is a serious academic infraction, and a deviation from academic norms.  Worse, ghostwriting harms society because it convinces doctors and patients to use harmful drugs that should be avoided.

Comparison with Non-Biased Review

For comparison, let's look at a very 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, published in Postgraduate Medicine: Volume 121: No.1 January 2009.(1-2)   The doctor's conclusion after reviewing the medical literature is: YES, There IS Evidence to support the claim that bioidentical hormones are safer and more effective than synthetics.  Dr. Holtorf’s  conclusion is quoted here:  

Dr. Holtorf cites 196 medical studies to support his conclusion.  I invite you to read his article for yourself by clicking on the hyperlinked reference for the internet version of this chapter.(1)  You are probably wondering, how is it possible for two smart doctors to come to the exact opposite conclusion? Dr. Cirigliano says NO they are not, and Dr. Holtorf says YES they are.

The answer is simple; none of the medical studies that Holtorf cites are mentioned in Dr. 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? This is another use of medical sampling, a commonly used  gimmick to slant or spin a medical study to get the  intended results.

The ghost written Cirigliano article selectively accepts only RCT studies as evidence. RCT means randomized controlled trial.  This is a drug trial with two groups of patients, a drug group and a placebo group.  Randomized means the patients are randomly selected for each group.  RCT trials are large and very expensive drug 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, Dr. 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. Dr. Holtorf's article also includes basic science and animal studies.   If you search the medical literature, you will find no privately funded Randomized Controlled Trials (RCT) for Bioidentical Hormones because they are natural and cannot be patented.  A drug company would NEVER invest the millions for a RCT for a drug without the patent protection to insure a profit.  In any event, with the information currently available, it would be a breach of medical ethics to do a randomized controlled study comparing progesterone to the chemically altered progestins. The adverse effects of progestins, which cause breast cancer and heart disease, are well known.  Inflicting these adverse effects on a test group would be unethical.

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.

For references and links, see my web site: www.bioidenticalhormones101.com

Articles with Related Interest:

The Safety of Bioidentical Hormones

The Importance of Bioidentical Hormones

Chapter 11. Bioidentical Hormones and Medical GhostWriting

(1) (2)   http://www.postgradmed.com/index.php?article=1949   see also

The_Bioidentical_Hormone_Debate_Ken_Holtorf_MD-3.pdf
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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

(3) 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

(4) http://www.ncbi.nlm.nih.gov/pubmed/18928825  see also 

Hormones__in_wellness_and_disease_prevention_common_practices_current_state_evidence_Erika_Schwartz_Kent_Holtorf.pdf
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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.

(5) 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.

(6) 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.

(7) 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

(8) 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.

(9) 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 et al.

 (10) http://www.solaltech.com/doctors/3/Bioidentical%20Hormone%20Therapy--%20Cirigliano.pdf    MichaeI Cirigliano MD. 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,  ACKNOWLEDGMENTS: I received editorial assistance from Eugene R.Tombler, Ph.D., Florencia Schapiro, Ph.D., and Monica Ramchandani, Ph.D., of PharmaWrite,LLC.

(11) http://grassley.senate.gov/about/upload/Senator-Grassley-Report.pdf Grassley Senate Report

(12) 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

(13) http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000230  Ghostwriting at Elite Academic Medical Centers in the United States,”  Jeffrey R. Lacasse and Jonathan Leo, “Ghostwriting at Elite Academic Medical Centers in the United States,” PLoS Med, 2010; 7(2): 1-4.

(14) 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.

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

(16) http://www3.interscience.wiley.com/cgi-bin/fulltext/122204937/PDFSTART  Bioethics ISSN; 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

(17) http://publicationethics.org/blogs/ghostauthors-ghost-management-and-manipulation-medical-research   Ghostauthors, ghost management and the manipulation of medical research

(18) http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000230   Ghostwriting at Elite Academic Medical Centers in the United States. PLoS by Jeffrey R. Lacasse and Jonathan Leo

(19) 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.

(20) 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.

(21) 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

(22) http://www.ama-assn.org/public/peer/7_15_98/jpv80004.htm  Prevalence of Articles With Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals . (JAMA. 1998;280:222-224) Annette Flanagin et al.

(23) 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

(24) http://www.nytimes.com/2009/08/05/health/research/05ghost.html?_r=1&ref=health   Medical Papers by Ghostwriters Pushed Therapy August 4, 2009

(25) 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

(26) 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

(27) 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.

(28) http://www.cmaj.ca/earlyreleases/9sept09_ghostwriting.dtl   Roger Collier, CMAJ September 9, 2009 Prevalence of ghostwriting spurs calls for transparency

(29)  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

(30) http://cat.inist.fr/?aModele=afficheN&cpsidt=17214001 Sexuality, Reproduction and Menopause Volume 3, Issue 2, October 2005, Pages 68-71 Elsevier Inc.“Bioidentical” estrogens: Hope or hype?  Maida Taylor MD, MPHa, , , Clinical Director Women's Health, Clinical Research & Medical Affairs—Endocrinology, Novo Nordisk Inc.

(31) 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.

(32) 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

(33) 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

(34) 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.