Brainstorm Health: Flu Vaccines and Pregnancy, Mylan Slams Allergan, Single Payer Bill

Good morning, readers! This is Sy.

A new study published in the journal Vaccine making the rounds Wednesday is the first to suggest a link (i.e., a correlation, not causation) between pregnant women taking a certain form of the flu vaccine multiple years in a row and miscarriages.

The research, conducted by Centers for Disease Control (CDC) scientists and others from the Marshfield Clinic in Wisconsin and Kaiser Permanente, analyzed the immunizations of 485 pregnant women who had regular baby deliveries as well as 485 women who had miscarriages during flu seasons in 2010-2011 and 2011-2012. In the group of women who miscarried, there was a small but significant number who received vaccines to protect against the H1N1 flu virus strain two years in a row, including one shot within 28 days prior to their miscarriages; this link was only apparent in the women who got the vaccinations in consecutive seasons.

Researchers stressed that this observational data isn't nearly strong enough to warrant changes to vaccine recommendations. "This study does not and cannot establish a causal relationship between repeated influenza vaccination and [miscarriage], but further research is warranted," wrote the study authors.

The CDC is clear in its guidelines that pregnant women in any trimester of their pregnancies should get the flu vaccine. "Flu is more likely to cause severe illness in pregnant women than in women who are not pregnant. Changes in the immune system, heart, and lungs during pregnancy make pregnant women (and women up to two weeks postpartum) more prone to severe illness from flu, including illness resulting in hospitalization," states the public health agency.

The new research, despite its very real limitations and caveats, is still a call for more research into this arena, CDC officials said. For instance, it's possible that pregnant women had a particular immunological response to taking an identical H1N1 vaccine on multiple occasions. But there simply isn't enough information at this time to draw any sort of definitive conclusion.

An unfortunate outcome, said the study authors, would be if the preliminary findings fueled anti-vaccine hysteria and stopped pregnant women from getting the vaccinations that could protect both them and their babies—and which have been proven safe and effective in numerous previous studies.

Read on for the day's news.

Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

DIGITAL HEALTH

Huawei, Samsung pursue senior-focused health features in smartwatches. Smart device makers Huawei and Samsung are both partnering with firms to add health monitoring features directed at seniors to their smartwatches. The applications would include heart rate and blood pressure monitoring in addition to other biometrics, and also alert caretakers when their sick relatives have exited their "safe zones." (MobiHealthNews)

INDICATIONS

Mylan slams Allergan's Mohawk tribe patent deal. EpiPen maker Mylan is blasting Botox maker Allergan's unusual patent arrangement with a northern New York Native tribe. The Allergan-Saint Regis Mohawk tribe deal relies on the tribe's sovereign nation status as a mechanism for swatting down intellectual property challenges to one of Allergan's key drugs. "[Allergan is] attempting to misuse Native American sovereignty to shield invalid patents from cancellation," Mylan argued in federal court Monday. (Reuters)

The new clinical trials site: Doctor's offices? Dr. Amy Abernethy, chief medical officer at the ambitious health tech firm Flatiron Health, and the FDA's Dr. Sean Khozin are out with a new commentary in the Wall Street Journal arguing that clinical trials need to be dragged into the 21st century in order to boost enrollment and identify the most effective therapies. One suggestion they have? Making it easier for such studies to be conducted close to home. "If local physicians can participate in conducting real-world randomized clinical trials in their own practices, new uses of approved drugs could be carefully studied, potentially generating evidence supporting approval of a new use," they write. "Real-world clinical trials could also limit disruptions to patients’ lives by reducing the need for long-distance travel." (Wall Street Journal)

THE BIG PICTURE

Two new health care plans to be released today. Details about a pair of diametrically opposed health care bills are set to be unveiled in the Senate today. One piece of legislation, the Graham-Cassidy-Heller-Johnson bill to repeal and replace Obamacare, faces long odds of passage in the Senate prior to an end-of-September deadline; the other, Bernie Sanders' single payer legislation, has been scooping up Democratic support but likely has even less chance of passing the GOP-controlled chamber. (Fortune)

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