Undisclosed Financial Conflicts of Interest: Risk to Pregnant Women & Unborn Fetuses?

by Vera Sharav
Alliance for Human Research Protection

The inordinate undisclosed influence brought to bear by drug companies on medical practice is undermining the credibility of recommended medical practice. Case in point: new recommendations for the treatment of pregnant women would increase their ingestion of powerful drugs.

Despite lack of adequate evidence of safety from serious risks of harm, the influential National Partnership for Maternal Safety, is promoting expanded indications for initiating treatment for depression and the prevention of thromboembolism (among other conditions) in pregnant women.

The Partnership for Maternal Safety published seven articles in one of the leading obstetrics journals, The Green Journal, which is the official journal of the American College of Obstetricians and Gynecologists.

One pesky detail missing from those articles is full disclosure of the significant financial conflicts of interest whose disclosure might lead readers to suspect the justification for those radical treatment recommendations by the Partnership for Maternal Safety.

Why were those financial ties to 13 drug manufacturers withheld from the wide and influential physician readership of the OBG Green Journal?

Below is a letter of complaint by Adam Urato, MD, Chief, Maternal-Fetal Medicine, MetroWest Medical Center, Framingham, MA.

We have concerns about the Green Journal’s recent Correction on seven of the articles written by the National Partnership for Maternal Safety.  We are concerned with both the nature of the correction and the recommendations made by the partnership.

The correction was unclear and failed to provide proper disclosure.  The National Partnership has significant financial ties to numerous corporations including Abbvie, Allergan, AMAG Pharmaceuticals, Bayer Health Care, Ferring Pharmaceuticals, Hologic, Illumina, Johnson and Johnson, Masimo, Myriad, Pfizer, Premier, and Salus Global.¹  This information should be presented to readers.  These ties were made transparent to readers neither in the original seven articles nor in the Correction. Also, the Correction was not available in the June, 2019 online edition of the Green Journal—that page was missing in the Table of Contents.  (It was only in the June print version.)  Online readers should have had clear access to this important Correction as well.  Finally, corrections have not been posted on each of the seven articles online—as should be standard.

We are also concerned that financial interests could play a role in a number of the recommendations by the Partnership that could be expected to significantly increase the prescription of drugs for pregnant women. For example, the National Partnership has been recommending a radical new approach to care of our patients—where large numbers of them are placed on anticoagulants.  The risks of this are unknown but may be considerable.²  There is little scientific evidence of benefit to support such an approach.³  Other approaches (e.g. mechanical prophylaxis and ambulation) have been proven effective.⁴  The recommendations of the National Partnership would lead to a dramatic increase in the number of women placed on anticoagulation and medical costs.³  It  is imperative that obstetrical providers, pregnant women, and the public be informed that the National Partnership is funded by three companies that manufacture or sell anticoagulants —companies who would directly benefit financially from the approach they recommend.

This episode represents a major failure of disclosure and we believe that the Partnership’s recommendations should undergo review given these undisclosed conflicts of interest.  We are asking the Green Journal to please conduct a more thorough investigation into the lack of disclosure, provide a more complete explanation to readers, and outline a clear path forward to prevent this from happening again.

References

-1. https://safehealthcareforeverywoman.org/about-us/industry-forum/. Accessed June 29, 2019.

-2. Kotaska A.  Postpartum venous thromboembolism prophylaxis may cause more harm than benefit: a critical analysis of international guidelines through an evidence-based lens.  BJOG. 2018 Aug;125(9):1109-1116.

-3. Sibai BM, Rouse DJ.  Pharmacologic Thromboprophylaxis in Obstetrics: Broader Use Demands Better Data.  Obstet Gynecol. 2016 Oct;128(4):681-4.

-4. Clark SL, Christmas JT, Frye DR, Meyers JA, Perlin JB. Maternal mortality in the United States: predictability and the impact of protocols on fatal post cesarean pulmonary embolism and hypertension-related intracranial hemorrhage. Am J Obstet Gynecol 2014;211:32.e1–9.

If you want to add your name to those objecting to the concealment of financial conflicts of interest from readers of the Green Journal, please include your title (MD, PhD etc). If you want to add an affiliation that’s fine; you can specify “for identification purposes only” as needed. Signing the attached letter only indicates that you are concerned about failure to disclose financial conflicts; it does not require that you appraise or reject the science behind the recommendations of the Partnership.

Dr. Adam Urato can be reached at: Adam.Urato@steward.org

This must be returned no later than July 26.

Read the article at Alliance for Human Research Protection.