Related Topics: HRT, Natural Progesterone, Opinion, Research, Treatments

Bioidentical Hormones and Medical GhostWriting, the Latest Scandal

Dr Dach reveals how pharmaceutical companies are paying ghost writers to produce medical articles for publication that attempt to convince doctors to prescribe synthetic hormones instead of bioidenticals.

Dr Jeffrey Dach

Intro by AnnA Rushton:

Why is My Doctor Opposed to Bioidentical Hormones?

When this question came up on Dr Dach’s website I was intrigued with his response as I am both a ghostwriter and someone who is passionately concerned that women receive the information they need to stay healthy.  As Editor of the bio hormone health site I am delighted that we can offer such a wide and expert range of opinions on the many aspects of hormonal health that concern us all.

The following blog from Dr Dach will I am sure cause you to think next time you read in the newspapers of some definitive statement about the medical profession’s opinion on natural hormones, or the latest “proof” on HRT and synthetic 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?”

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.

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 .

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.

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:

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.

Beral V; Million Women Study Collaborators. Breast cancer and
hormone-replacement therapy in the Million Women Study. Lancet.
2003;362(9382):419–427.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.
*****************************

To read more on Dr Dach’s work please visit his website at www.jeffreydach.com If you have any questions or comments you can contact him via the website


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Please feel free to discuss this article in the comments section below, but note that the author cannot respond to queries made there.
Comments 4
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