How conflicts of interest put new mothers at risk

In recent years, the maternal mortality crisis in the United States has received more recognition in the media and among policymakers and patient safety groups. However, it has come to light that some pharmaceutical companies may be trying to promote greater use of medications unnecessarily, under the guise of improving maternal safety.

In 2016, the National Partnership for Maternal Safety (NPMS) released a list of recommendations for reducing deaths from blood clots in pregnant and postpartum women in the journal Obstetrics & Gynecology, popularly known as the “Green Journal.” One of these recommendations was expanding the use of blood thinners to most women after a cesarean birth. Since nearly one third of births in the US are by c-section, that’s about 1.3 million women a year who would be put on blood thinners after giving birth. 

“It’s an uncontrolled experiment on women who just have a baby” — Shannon Brownlee

Researchers responded to this recommendation with alarm. In an accompanying editorial in Obstetrics and Gynecology, two obstetricians warned that the broad expansion of blood thinners to all women who have a c-section “is not justified by the available data and has the very real potential of doing more harm than good.” Given the rate of blood clots in new mothers, approximately 1 million women would require blood thinners to prevent even one maternal death from cesarean delivery–associated pulmonary embolism, the authors wrote. Abiding by this recommendation would cost as much as $130,000,000 and expose thousands of women to the risk of severe bleeding and other side effects. 

“It’s an uncontrolled experiment on women who just have a baby,” said Shannon Brownlee, Lown Institute Senior Vice President, about the NPMS recommendation.

Since 2016, some obstetricians have noticed a difference in the number of pregnant and postpartum women who are being placed on blood thinners. One of these physicians is Dr. Adam Urato, Chief of Maternal-Fetal Medicine at the MetroWest Medical Center in Framingham, Massachusetts. “Over the last few years, we have seen this real ‘push’ to get pregnant women on blood thinners,” said Urato.

“Over the last few years, we have seen this real ‘push’ to get pregnant women on blood thinners.”

Urato was concerned by increasing pressure at his institution to adopt the NPMS recommendations on blood thinners, and decided to look deeper into the organization. What he found was that NPMS has significant has financial ties to industry companies including Abbvie, Allergan, AMAG Pharmaceuticals, Bayer Health Care, Ferring Pharmaceuticals, Hologic, Illumina, Johnson and Johnson, Masimo, Myriad, Pfizer, Premier, and Salus Global, through their “Industry Forum.” However, the 2016 recommendations did not include any of these conflict of interest disclosures from the NPMS.   

“It astounds me that the National Partnership for Maternal Safety submitted this article to the Green Journal without disclosing these industry ties,” said Urato. Urato notes that Obstetrics and Gynecology elicits potential conflicts of interest several times in their submission process, making the omission of these conflicts even more outrageous.

It took three years for Obstetrics and Gynecology to publish a correction, which noted that NPMS receives industry funding from three companies that manufacture or sell blood thinners. This correction appeared in the print version of the journal only, not the online version, making it even more difficult to find. Additionally, none of the names of the corporations that are linked to NPMS are mentioned in the disclosure. “This isn’t a transparent disclosure statement,” said Urato. “I give the journal credit for running the correction, but the way it was handled was a little bizarre.”

Urato and a group of obstetricians wrote a letter to Obstetrics and Gynecology, demanding a thorough investigation into why the conflicts were not disclosed, and, more importantly, a plan of action for how to prevent this from happening again. The letter has now been signed by more than forty physicians, researchers, nurses, lawyers, journalists, and others from around the world, and is currently under review at the journal.

“We really need public attention on this issue and we need to make sure that this type of industry influence is not allowed to be hidden and go unchecked,” said Urato.