Tag Archives: FDA

Why Does The FDA Approve Cancer Drugs That Don’t Work

BRIAN KLEPPER Posted 10/23/15 on The Health Care Blog A new study in JAMA Internal Medicine finds that two-thirds of cancer drugs considered by the US Food and Drug Administration (FDA) over the past five years were approved without evidence that … Continue reading

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Posted in Analytics, Brian Klepper, Conflicts of Interest, Health Care Cost, Innovation, Life Sciences, Market Dynamics, Policy/Law/Regulation | Tagged , , | 3 Comments

Another Stent Device Biting The Dust

Tom Emerick Posted 3/26/12 on Cracking Health Costs We’re seeing a trend.  The FDA approves a stent without proper testing.  Death and complication rates with the new stent increase, the FDA is force to review it. Remember the controversy over … Continue reading

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Posted in Conflicts of Interest, Market Dynamics, Medical Management, Quality, Supply Chain, Tools | Tagged , , , , , | Leave a comment

The Latest Advisory Committee at FDA

Merrill Goozner Posted 12/7/11 on Gooz News Is the Food and Drug Administration stacking the deck against a negative decision at tomorrow’s safety hearing for oral contraceptives that contain drospirenone, include Bayer’s Yasmin? Or is it laying the groundwork to … Continue reading

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On the FDA’s Decision To Withdraw Avastin’s Breast Cancer Indication

Merrill Goozer Posted 11/18/11 on Gooz News They did the right thing. Two clinical trials showed no improvement in mortality among women with metastatic breast cancer. Those trials didn’t even replicate the delay in progression of disease that had been shown in … Continue reading

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Posted in Analytics, Benefits, Innovation, Life Sciences, Market Dynamics, Medical Management, Physicians, Policy/Law/Regulation, Quality | Tagged , , , , , , , | Leave a comment

Buck for the Bang: Premium Med-Tech Pricing

Adi Renbaum Posted 10/31/11 on Medical Device Daily. Cook Medical’s Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on … Continue reading

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More On Supplements

Dov Michaeli Posted 1o/16/11 on The Doctor Weighs In I know when I tread on people’s cherished beliefs when I get pushback from readers, some of it ,let’s say, quite emotional. But that’s good. It is important that we challenge … Continue reading

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Posted in Consumerism, Innovation, Life Sciences, Market Dynamics, Medical Management, Physicians, Policy/Law/Regulation, Quality | Tagged , , , , , | 1 Comment

A Victory for Coverage With Evidence-Development

Merrill Goozner First posted 9/8/11 on GoozNews A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent … Continue reading

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A High Price for Rare Cancer Drugs

Merrill Goozner First posted 8/30/11 on Gooz News Pfizer last week won Food and Drug Administration “accelerated approval” for Xalkori (crizotinib) for a rare form of metastatic lung cancer that strikes about 3 percent of people — almost always non-smokers … Continue reading

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IOM Calls For Overhaul of Device Regulation

Merrill Goozner First posted 7/29/11 on Gooz News The Institute of Medicine committee that’s been reviewing medical device regulation for the past two years called this morning for a sweeping overhaul of Food and Drug Administration rules that allow some implanted devices to … Continue reading

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Posted in Innovation, Market Dynamics, Medical Management, Policy/Law/Regulation, Quality, Reform | Tagged , , , , | Leave a comment

Niseritide, the “Lost Decade”, and the Pinto

Patricia Salber First posted 7/14/11 on The Doctor Weighs In Eric Topol, MD wrote an interesting commentary in the July 7, 2011 issue of the New England Journal of Medicine, titled “The Lost Decade of Nesiritide.” Nesiritide is a drug … Continue reading

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Posted in Analytics, Innovation, Market Dynamics, Medical Management, Physicians, Policy/Law/Regulation, Quality, Reform | Tagged , , , , , , | Leave a comment

Healthcare Associated Infections: What Is The Message, and What Can We Do About Them?

David Harlow First posted 7/8/11 on Health Blawg The good people at GE and JESS3 have come up with an HAI infographic.  It’s pretty, and it conveys the horrible information that many of us already know — healthcare associated infections kill … Continue reading

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We Will Pay For Avastin

Merrill Goozner First published 6/30/11 in The Fiscal Times: How much should you, your insurer or the government pay for an extra month of life? How much is an extra month of hope worth, even if doesn’t extend life? Those questions never … Continue reading

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Posted in Analytics, Innovation, Life Sciences, Market Dynamics, Medical Management, Physicians, Policy/Law/Regulation, Quality, Reform | Tagged , , , , , | 1 Comment

Lawyers and Medical Decision-Making

Merrill Goozner First posted 6/28/11 on Gooz News We’ve heard a lot over the years about the inappropriate role of lawyers in the medical system. The complaints usually center on trial lawyers who sue physicians for malpractice and drug companies … Continue reading

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GAO: FDA Can’t Monitor Device Recalls

Merrill Goozner First posted 6/21/11 on Gooz News The Government Accountability Office has weighed in on the failure of the Food and Drug Administration to properly monitor medical device recalls. Its review of the 3,510 recalls between 2005 and 2009 — 40 … Continue reading

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Posted in Analytics, Market Dynamics, Medical Management, Policy/Law/Regulation, Quality, Reform | Tagged , , , , , , | Leave a comment

Soaring Medical Costs Pinned on Medical Devices

Merrill Goozner First published 6/07/11 in The Fiscal Times While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions,  a fight is brewing that could have a major impact … Continue reading

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Posted in Analytics, Innovation, Market Dynamics, Medical Management, Physicians, Policy/Law/Regulation, Quality | Tagged , , , , , , | Leave a comment