Medical Ghostwriting Deemed a Fraud on the Court

by Jeffrey Dach MD

Stern and Lemmens, two Toronto Law Professors, have joined forces in a scathing denouncement of medical ghostwriting in the August 2 PLOS journal.(1)  The two law professors cited a 1944 Supreme Court case dealing with ghost writing, Hazel-Atlas Glass v. Hartford-Empire Co. (1944).

In this patent dispute case, the Supreme Court was fooled by a ghost written trade article presented in defense of a patent. A few years later, when Anti-Trust litigation revealed that the article had been “ghost written”, the Court overturned the patent decision, and ruled that ghost writing in the trade literature amounted to a “fraud on the court”, and the lawyers who had used the “ghost written” article were disbarred from practice.(2) This same concept applies to the pharmaceutical industry. Above left image: Ghost Image on cover of old comic book courtesy of wikimedia commons.

Current examples of ghost writing by the drug industry planted into the medical literature include drugs such as:

1) Vioxx (rofecoxib) a heavily promoted anti-inflammatory NSAID drug, later found to cause heart attacks.(3)(10-11)

2) Prempro (combined estrogen/progestin), a synthetic hormone combination drug heavily promoted for years as hormone replacement for women. This was found to cause cancer and heart disease in the WHI (Women’s Health Initiative Study).(4)(12-13)

3) Paxil (paroxetine), an SSRI antidepressant found to be no better than placebo for most patients in treatment for depression, and also found to cause suicidal impulses (5,6).

There are many others.This quote is from the Adriane J. Fugh-Berman article.(4)

“Ghostwriting has been documented for drugs other than Prempro. For example, Forest Laboratories’ 2004 marketing plan for Lexapro (escitalopram) [95], stated: “Bylined articles will allow us to fold Lexapro messages into articles on depression, anxiety and comorbidity developed by (or ghostwritten for) thought leaders” [96]. Ghostwriting has also been documented in the promotion of Paxil (paroxetine) [97]–[100], “Fen-phen” (fenfluramine and phentermine) [101], Neurontin (gabapentin) [102], Vioxx (rofecoxib) [103], and Zoloft (sertraline) [104].”

Examples of Fraud – Ghost Writing in the Synthetic HRT medical literature from Adriane J. Fugh-Berman (4)

Mitigating Perceived Risks of Breast Cancer- Fraud

Nachtigall LE. Sex Hormone-Binding Globulin and Breast Cancer Risk
Primary Care Update for Ob/Gyns 1999; 6 (2):39-45.

Eden J. Progestins and breast cancer. Am J Obstet Gynecol. 2003
May;188(5):1123-31.

Cefalu T. The Use of Hormone Replacement Therapy in Postmenopausal Women with Type 2 Diabetes. J Women’s Health 2001; 10 (3):241-255

Promoting Off-Label Uses for Alzheimers’, Parkinsons– Fraud

Fillit, M. The Role of Hormone Replacement Therapy in the Prevention of Alzheimer Disease. Arch Intern Med. 2002;162(17):1934-42.

Birge SJ. Practical Strategies for the Diagnosis and Treatment of Alzheimer’s Disease. Clinical Geriatrics 1999 7(4):56-74.

Shulman L. Is there a Connection Between Estrogen and Parkinson’s Disease? Parkinsonism Relat Disord. 2002;8(5): 289-95

Sherwin BB. Mild Cognitive Impairment: Potential Pharmacological Treatment Options. J Am Geriatr Soc. 2000;48(4):431-41.

Brincat M, Baron Y, Galea R. Estrogens and the Skin. Climacteric 2005;8(2):110-23.

Snow KK, Seddon JM. Age-Related Eye Diseases: Impact of Hormone Replacement Therapy and Other Risk Factors. Int J Fertil Womens Med. 2000 Sep-Oct;45(5):301-13

Freedman, MA. Quality of Life and Menopause: The Role of Estrogen.  J Women’s Health 2002;11(8):703-718.

Bachman G, Leiblum S. The Impact of Hormones on Menopausal Sexuality: a Literature Review. Menopause 2004;11 (1): 120-130.

Mitigating Perceived Risks of Breast Cancer

Curtis M. Selective Estrogen Receptor Modulators: A Controversial Approach for Managing Postmenopausal Health. J Women’s Health 1999; 8 (3) : 321-33

Curtis MG. Comparative Tolerability of First-Generation Selective Estrogen Receptor Modulators in Breast Cancer Treatment and Prevention. Drug Safety 2001;24(14):1039-53

Bachmann GA. Menopausal Vasomotor Symptoms: a Review of Causes, Effects and evidence-Based Treatment, J Reprod Med. 2005 Mar;50(3):155-65.

Ansbacher R. The Pharmacokinetics and Efficacy of Different Estrogens are Not Equivalent. Am J Obstet Gynecol. 2001 Feb;184(3):255-63

No author listed. Generic and Therapeutic Substitution. National Pharmacy Compliance News 2000;4th quarter:2-3.

Defending Cardiovascular Benefits – Fraud

Mosca L. Hormone Replacement Therapy in the Prevention and Treatment of Atherosclerosis. Curr Atherosclerosis Reports 2000 Jul;2(4):297-302.

Rackley CE. New clinical markers predictive of cardiovascular disease: the role of inflammatory mediators. Cardiol Rev. 2004;12(3):151-7.

Koh KK. Can a Healthy Endothelium Influence the Cardiovascular Effects of Hormone Replacement Therapy? Int J Cardiol. 2003;87(1):1-8

Positioning Low-dose Therapy – Fraud

Lobo R, Whitehead M. Is Low-Dose Hormone Replacement Therapy for Postmenopausal Women Efficacious and Desirable? Climacteric. 2001 Jun;4(2):110-9.

Maddox RW. The Efficacy and Safety of Low-dose Hormone Therapy. US Pharmacist 2004 (June).

Guilty of Fraud on the Court

The above are fraudulent ghostwritten articles were “planted” into the medical literature.(4) They were written by paid authors from Designwrite, and academic “opinion leaders” were selected to lend their name as author to sway the opinions of others. These “opinion leaders” are all guilty of “Fraud on the Court”.

Bioidentical Hormones are Safe and Effective

Bioidentical Hormones are safer and more effective than synthetic chemically altered hormones. Smart women have abandoned synthetic hormones, and have turned to bioidentical hormones as safe and effective. What convinced them?

1) The revelations of ghostwriting in the HRT literature.
2) The many medical studies showing synthetic hormones cause cancer and heart disease.
3) The many medical studies showing safety and efficacy of bioidentical hormones.
4) The decrease in breast cancer rates of 9% in the years 2003-2004 after the WHI study was terminated early because of increased breast cancer in the Prempro group.

Articles with related interest:

Bioidentical Hormones and Medical Ghost Writing, the Latest Scandal Why is My Doctor Opposed to Bioidentical Hormones?

HRT Does Not Cause Breast Cancer

References

1) Stern, Simon, and Trudo Lemmens. “Legal remedies for medical ghostwriting: imposing fraud liability on guest authors of ghostwritten articles.” PLoS Med 8.8 (2011): e1001070.

2) Hazel-Atlas Co. v. Hartford Co., 322 U.S. 238, 64 S. Ct. 997, 88 L. Ed. 1250 (1944).

3) FDA NEWS RELEASE September 30, 2004
FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product 

4) Fugh-Berman, Adriane J. “The haunting of medical journals: how ghostwriting sold “HRT”.” PLoS Med 7.9 (2010): e1000335. The haunting of medical journals how ghostwriting sold HRT Fugh-Berman Adriane J PLoS Med 2010

4a) JAMA. 2003;289(24):3243-3253 Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women – The Women’s Health Initiative Randomized Trial by   Rowan T. Chlebowski, MD, PhD; et al for the WHI Investigators Influence of Estrogen Plus Progestin on Breast Cancer in Postmenopausal Womens Health Initiative Chlebowski Rowan T Jama 2003

5) SSRI Antidepressants no better than Placebo JAMA Article

6) Culpepper, Larry, et al. “Suicidality as a possible side effect of antidepressant treatment.” Primary care companion to the Journal of clinical psychiatry 6.2 (2004): 79.

7) Bosch, Xavier, Bijan Esfandiari, and Leemon McHenry. “Challenging medical ghostwriting in US courts.” PLoS Med 9.1 (2012): e1001163.

8) Ethical pharmaceuticals a deeper look at the ethics in pharmaceutical public relations Walsh William M 2006

9) Schofferman, J., F. T. Wetzel, and C. Bono. “Ghost and guest authors: you can’t always trust who you read.” Pain medicine (Malden, Mass.) 16.3 (2015): 416.

10) Ghostwriters Used in Vioxx Studies, Article Says
By STEPHANIE SAULAPRIL 15, 2008

11) Krumholz, Harlan M., et al. “What have we learnt from Vioxx?.” BMJ: British Medical Journal 334.7585 (2007): 120. What have we learnt from Vioxx Krumholz Harlan M BMJ 2007

12) Medical Papers by Ghostwriters Pushed Therapy By NATASHA SINGER August 4, 2009

13)  Bosch, Xavier. “Exorcising ghostwriting….” EMBO reports 12.6 (2011): 489-494.

Jeffrey Dach MD
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