Author: Suzanne B. Robotti

FDA

Every drug has a side effect. For that reason, a drug that doesn’t work must be removed from use. Drugs like Makena, which don’t work and may harm patients, is the reason that both MedShadow and DES Action USA exist. And when it comes to Makena specifically, we’re thrilled to announce we have made massive progress! Thanks to more than a thousand of your signatures on our petition, the FDA’s Center for Drug Evaluation and Research (CDER) recommended on October 5th that the drug be removed from the market. Makena is a hormone given to pregnant women who are told…

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As we all emerge from our bubbles of limited contact with others, we are walking straight into the double whammy of flu season and COVID-19 germs. Can your body fight off exposure to the flu and COVID? Your immune system feeds off the basics of life — sleep, movement, food and love. So, give your immune system all the help it needs by following expert advice.  Sleep: Hit the snooze button. (You know you want to)  Lack of sleep wreaks havoc on an already-shot immune system, Freida Wiley, PharmD, told Medshadow.  Some drugs will put you to sleep, but all…

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Among growing concern about Breast Implant Illness (BII) and a cancer linked to breast implants, the FDA announced new guidelines for patient education about saline or silicone gel fillers used in breast implants. The guidelines are to ensure that “patients considering breast implants have the information they need for a balanced discussion with their physicians regarding the benefits and risks of breast implants.” (See the story of an FDA Committee member’s experience at the meeting on breast implants, Breast Implants: Should They be Banned?) About three times as many women have breast augmentation as those who have reconstruction. Regardless of why…

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In early August, my husband and I had 17 people from five different states stay at our home for our annual week-long family gathering. The prospect of my family, especially my husband’s 97-year old mother, gathering during COVID under one roof for a week scared the hell out of me.  My close friends who are familiar with our “Robotti Weekend” asked me what we were going to do. We’ve been hosting it in our weekend house in New Jersey for more than 30 years. Last year we had 25 for the long weekend. Over time we’ve converted attic space and…

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Today the House Oversight Committee will hold a briefing on the FDA’s process for approving a safe and effective COVID-19 vaccine. The Chair of the Oversight Committee, Carolyn Maloney, asked me to speak to the staff organizing the speakers and questions. As a a member of the FDA’s Drug Safety and Risk Management Advisory Committee for the past three years, I’m familiar with the FDA approval process. Watch the House Oversight Committee’s live briefing below: I thought deeply about the development process for the vaccine — a process that is undoubtedly being hurried. Here is what I told the committee…

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It seems every time we learn something about COVID-19, it is contradicted within days. The most recent about-face still has me spinning: We were first told that COVID-19 germs spread to other people before symptoms appear, called “asymptomatic shedding,” and it was estimated to happen for up to two weeks before symptoms appeared.

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Will turning men into women save their lives? Of course, I am speaking facetiously. Doctors on the front line have noticed that women seem to survive COVID-19 better than men. A new report estimates that twice as many women survive as men. This has generated a debate among scientists: What is it that women have and men don’t? The answer that two different scientific teams have come up with is estrogen and progesterone. Perhaps these “women’s hormones” offer some protective veil? There is no theory offered as to why that would be. Pumping estrogen and the combination of estrogen/progesterone into…

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