Top of the morning to you. Another busy day is unfolding here on the Pharmalot campus, where we are mulling over our cluttered calendar and plotting our next moves as we await another winter storm. Perhaps, you can relate. After all, this is only the middle of the week and there is so much to be done. This calls, as you may imagine, for a hot cup of stimulation. We are sticking with the seasonal peppermint mocha for now, by the way. Feel free to join us. Meanwhile, here are some tidbits. The world is a busy place, yes? Hope you make your way today …
Acetaminophen, ibuprofen, and other non-steroidal anti-inflammatory drugs, or NSAIDs, are better than opioids at easing intense chronic pain in the back, knees, or hips, Reuters writes, citing research in the Journal of the American Medical Association. And opioids are no better than these other drugs at reducing how much pain interferes with daily activities like walking, working, sleeping, or enjoying life. “This study shows that extra risk doesn’t come with any extra benefit,” says lead study author Dr. Erin Krebs of the Minneapolis VA Health Care System.
Drug makers continue to keep rejection letters from the Food and Drug Administration under wraps, according to BioPharma Dive. Between 2010 and 2017, companies disclosed 29 so-called refuse-to-file letters, which means the agency refused to review an application, yet data provided by the FDA showed 73 such letters were issued over that same time period. “Part of the discrepancy [in the number of RTFs publicly disclosed versus the FDA count] may depend on how material the event is,” says Kurt Karst at the Hyman, Phelps & McNamara law firm.
I don’t think some ppl have really been in pain from failed back surgeries and cancer pain uh NO I can’t take the NSAIDS because it makes ulcers in my stomach which in returns makes me throw up blood.And regular Tylenol messes with my liver so bad.So doctors need to look at mris cats and and any other type if test to show them hey this patient is in pain instead of taking opioids away from patients they jydtvwant to get back a little of their life back cause they are bot only depressed from nor being the person they use to be but their nerves are a wreck from anxiety so before taking their meds look at all reports.I often wonder why have that medicine to bring ppl back after an overdose they may look at that again cause I feel that just maybe if we allow them to go it would take care of the opioid problem just saying.I feel ppl that overdose has made a decision not to go on this way so why make them stay when just maybe they want to go on.
So wonderful to have choices for lower back pain
-Behind Door # 1: opioids, and your on your way to drug rehab.
-Behind Door #2: Tylenol. Take a few grams a day and blow out your liver.
-Behind Door #3; Celebrex, and your aortic valve is history.
I’ll take my chances with the billy goat behind Door #4.
A Refuse to File letter from FDA is the ultimate form of rejection. An NDA has to be REALLY REALLY bad to earn an RTF. Marketing has always run the show but used to back off until Medical had enough data for a credible submission. An RTF letter used be as rare as a total solar eclipse. Now it’s all about deadlines and shareholder value. I can guarantee that the marketeers who set the deadlines for the NDA submissions that resulted in the 73 RTFs have collected their six figure bonuses and have moved on to other “opportunities”.
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