Fighting the medical establishment

Also: EPA proposes new regulations to limit PFAS in drinking water [View in browser](    [❤️]( March 14, 2023 Hi CommonHealth reader, For two decades, Dr. Adam Urato fought the medical establishment. This past week, he was vindicated. Here’s the backstory: The U.S. Food and Drug Administration has only ever approved one drug to prevent preterm births, which happen in about 10% of pregnancies and can cause life-long consequences. The drug is called Makena. It was widely accepted as the best care option available in high-risk pregnancies. But Urato wasn’t confident the drug worked. He publicly questioned it, testifying before the FDA and writing about it in [the media]( and [medical journals](. Fast forward to last fall, and an [FDA advisory panel]( voted to recommend withdrawing the drug from the market. Last week, the [company that makes Makena]( said it would voluntarily pull the drug. I called up Urato — an obstetrician who specializes in high-risk pregnancies at MetroWest Medical Center in Framingham — to get his reaction to the move and find out what it was like to stand up to the status quo. What convinced you to raise your voice against this popular drug and say, "Wait, something’s wrong here"? AU: "Approval for Makena was based on just one study, published in 2003. It started getting used like right out of the gate. But, from the get-go, it was clear that there were serious flaws with [the trial]( "It was a randomized, placebo-controlled trial, but the randomization basically failed. The group that got placebo was a much higher-risk group. "So, the study found the group getting Makena had a rate of preterm birth that was about 36%. And that is right about what we usually see for women who’ve had a [prior] preterm birth. So that didn't look like the drug was effective. But the placebo arm had a 55% rate of preterm birth. So it wasn't that the Makena really worked. It was just that the placebo arm had this crazy high rate of recurrent preterm birth. So, I was suspicious. "I thought, this is really weak science to justify injecting a whole bunch of women with a synthetic chemical compound." When did you decide to speak publicly against it? AU: "It was a combination of things. So, I had questions about the science, and then the observational studies that started coming out weren't showing benefit. But at the same time the company behind Makena, AMAG Pharmaceuticals, was saturating the market with advertising and showering cash on the professional medical societies. "Each month our journal, the Journal of the American College of Obstetrics and Gynecology, would come out with a banner advertisement wrapped around it for Makena. You literally couldn't access the scientific information in the journal without interacting with this big advertisement. It was everywhere. AMAG Pharmaceuticals made billions off this drug that didn’t seem to work, so that’s what did it for me." What was it like for you to speak out, given that the medical establishment had embraced Makena so fully? AU: "It was challenging. There was basically a scientific consensus that Makena was the standard of care. Everybody kind of jumped on board. A lot of colleagues I talked to didn't understand how weak the scientific foundation was for the drug. "I did get called in once by a supervisor who sat me down and said, ‘You know, it's a little bit atypical that you're not using this drug. It's outside the standard of care.’ There was no threat per se involved, but it's your supervisor, it's your boss. And so you worry, is this going to have an effect on me and my job?" And how does it feel now that Makena is officially off the market? AU: "I'm very happy. I think this is the right decision. What we’ve basically been doing for the last 20 years is injecting pregnant women, every week, with a synthetic hormone that doesn't benefit them. It doesn't help their babies, and it carries risks. It's a really big tragedy, a big mistake. "But I also feel bad because women that have had a prior preterm birth — and are at risk of another preterm birth — have no medications to help prevent it. It's an awful place to be in. As a physician, you want to be able to offer these patients something. And now it's clear that there's nothing. Urato had a lot more to say about what Makena's failure means for the pharmaceutical industry and for public trust in the medical establishment. You can [read more of our conversation here](. "It’s important for people not to miss what's happened here. 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