Heart Ring Slips Through FDA Loophole

Merrill Goozner

First published 5/23/11 on GoozNews

The Chicago Tribune had an important series over the weekend exposing conflicts of interest in the cardiovascular medical device industry, and the loopholes in regulatory oversight that allowed what appears to be a dangerous heart valve replacement part to escape Food and Drug Administration scrutiny. The latter story is by far the more important one. Here’s the details, from the Trib website:

Instead of being grouped with heart valves and implantable pacemakers, annuloplasty rings were put into a class with most catheters, sutures and hearing aids, which allows the medical device industry to gain approval for new rings without clinical studies.

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Medical Devices: PR vs. Reality

Merrill Goozner

First published 2/14/11 on Gooz News

Over the past several months, as my colleague Allison Bass pointed out last week, the medical device industry has launched a preemptive campaign to blunt the Food and Drug Administration’s long overdue overhaul of the way it approves joints, stents, pumps and other medical devices inserted in millions of American bodies every year. Triggered in 2009 by the ReGen Menaflex scandal, the FDA device review over the Obama administration’s first two years focused on the 510(k) approval process, which allows devices deemed substantially equivalent to previously approved devices to slide through their FDA approval process without undergoing clinical trial testing in humans. Recognizing that the law had created a huge loophole for devices whose malfunctioning would pose a serious risk to human health, the FDA asked the Institute of Medicine to conduct a full-scale investigation into the device review process. That report is due in June.

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Are We Seeing a Concerted Drug Industry Campaign Against the FDA?


First published 2/10/11 on Alison Bass’ blog.

There must be something in the air. Either that, or the drug and medical device industry has embarked on a concerted campaign to improve its tattered public image and bully the FDA into backing down from recent efforts to ensure that unsafe drugs and medical devices are kept from the market.

First appeared an op-ed piece in The Boston Globe early this week complaining that the average number of new drugs approved by the FDA since 2005 has dropped 33 percent and urging the FDA to once again speed up the process. The op-ed was penned by none other than Christoph Westphal, a biotech entrepreneur who made a mint when he sold his startup, Sirius, to GlaxoSmithKline in 2008 for a whopping $720 million.

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The Avastin Decision: A Rational Decision Or Rationing?


This column is a collaboration between KHN and The New Republic.

Originally published 1/04/11 on Kaiser Health News

I respect honest disagreements about policy. You think health care reform is a bad idea? That it will run up the deficit or make it harder to find a doctor? I think you’re wrong, but that’s a reasonable debate and I’m happy to have it, just as long as you’re truthful about what you are arguing and make some good faith effort to learn the facts.

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Social Networks and Life Science Companies: Balancing Regulation and Risk Aversion with Opportunity


Originally published here on 12/15/10 on Health Populi.

One in 3 managers in life science companies — including biotech, pharma, medical device and diagnostics firms — have no plans to engage with online social networks, according to a survey conducted by Deloitte. The key reasons for shying away from social networks include lack of guidelines offered by the Food & Drug Administration (FDA), concerns about consumer privacy, and low or uncertain return on investment.

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