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?"Left Image : Ghost Photograph, Man with the spirit of his second wife, by William Hope (1863-1933), Courtesy of National Media Museum and 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 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:
I received editorial assistance from Eugene R.Tombler, Ph.D., Florencia Schapiro, Ph.D., and Monica Ramchandani, Ph.D., of PharmaWrite,LLC..
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.
Ghostwriting is a form of plagiarism, and grounds for dismissal from most universities. Medical ghostwriting is especially pernicious because it is fraudulent, unethical, and harmful to society. The practice should be banned.
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:
"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. 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.
Important Point: Using The RCT Gimmick
The Randomized Controlled Trial (RCT) argument is a commonly used gimmick to claim there is “no evidence” for a natural substance. Basic science lab studies, animal studies, and epidemiological studies account for the vast majority of medical research and represent “medical evidence” as well. When convenient, the drug companies ignore this mountain of evidence favoring a natural substance competitor such as bioidentical hormones. They will then plant into the medical literature a series of biased, ghostwritten articles restricting discussion to RCTs as the only acceptable form of “evidence” .
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.
Chapter 11. Bioidentical Hormones and Medical GhostWriting
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
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.