Within the next year, millions of people will receive one of three, or more, new COVID-19 vaccines. Two of them will likely be mRNA-based vaccines, never before approved for human vaccine use. With technology that the Centers for Disease Control and Prevention (CDC) has developed, we could track COVID-19 vaccine recipients and gather massive amounts of data comparing in the real world which vaccine(s) is the most effective, for how long, with which subpopulations and how safe? But we’ll only know that if we act now. Are we about to squander this historic opportunity? The CDC has an app to…

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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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Is is safe? Is it effective? Those are the 2 major questions that the FDA asks. Without a “yes” for both, the FDA won’t approve that use for a drug. On March 10, 2016, it was announced that Amarin’s suit against the FDA has been settled and both have agreed to live with the previous federal court ruling. That ruling was that the FDA could not prohibit Amarin’s truthful promotion of a drug for off-label (unapproved) uses because doing so would violate the protection of free speech. Is this a win for our First Amendment? Not in my opinion. I…

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FDA

Following are some wonderfully interesting articles on issues in health care. We did not report on them earlier because MedShadow Foundation’s mission is to gather and share information on the side and long term effects of prescription drugs and these articles study the system of medicine. However, I can’t bear to not share these ideas. One Drug, Two Names, Many Problems, OpEd, New York Times, Dec. 1, 2013 This is an “Of course!” article, first published in the NYT blog, Opinionator, but I found it when published as an OpEd piece. The writer, Theresa Brown, states a problem that I…

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“Are there any substantial studies that focus on the side effects of long-term use of SSRI antidepressants?” This was the question posed recently in the New York Times “Ask Well” column.  Everybody should be asking their doctor, their friends and their legislators why this is the response: “The short answer is no. But your question gets to the heart of an important problem that we have in this country: that all medications are approved by the FDA on the basis of relatively short-term studies, even though many are used long-term for medical and psychiatric disorders that are chronic, if not…

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