Recently we’ve had to familiarize ourselves with yet another virus, monkeypox. As of July 25,…
Author: Suzanne B. Robotti
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…
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…
“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…
Real world data is hot. Real world data is just what it sounds like: information on how a drug acts in the marketplace where variables cannot be controled. For better or worse, the information submitted to the FDA for drug approval is limited. It is tested on a hand-selected group of people most often as the only drug the control group takes. Generally the questions the FDA focuses are are: is this drug better than a placebo? Is it safe to take? Do the side effects outweigh the benefits? Once approved and in the marketplace, real world data can result…
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