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 the original trial that led to accelerated approval in 2007.

Now comes the firestorm from patient advocacy groups, who will use anecdotal stories to claim the drug works for some women. The drug industry’s flaks and sycophants will suggest the FDA’s overweaning regulatory apparatus is stifling innovation.

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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 our beliefs, and if the sacred cows don’t stand up to scrutiny, we should slaughter them (to our Hindu readers – I meant it as a metaphor, honestly).

The October 14 of MedPage Today had an interesting article on the issue of vitamins and other food supplements. Highly recommended. Here are a few choice quotes:

“As the dust begins to settle, physicians interviewed by MedPage Today and ABC News agreed on a bit of simple wisdom –a healthy diet is more important than a fistful of supplements”.

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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 enter the market without adequate safety and effectiveness testing. The process — known as 510(k) — provides for minimal testing of devices if they are deemed “substantially equivalent” to a device that is already on the market.

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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 for heart failure symptoms (e.g., shortness of breath) that was approved by the FDA in 2001. Since that time, according to Dr. Topol, “well more than $1 Billion was wasted on purchasing the drug.”

It turns out that the FDA approved the drug was based on a relatively small, not particularly well done clinical trial that showed improvement in self-reported symptoms of shortness of breath 3 hours after the drug was administered. Once the drug was approved, the drug was marketed like crazy. For profit outpatient heart failure “tune up” clinics opened so that heart failure patients could get weekly intravenous infusions of the drug.

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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 came up during this week’s Food and Drug Administration appeal hearing on the agency’s decision to withdraw approval from the Roche-Genentech drug Avastin for advanced metastatic breast cancer. But they will be front and center in the years ahead as medical science and the drug industry continue to bring advanced cancer therapeutics to market that have only marginal effects on a devastating disease that takes half million lives a year, most of whom are elderly and receive treatment through Medicare.

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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 for failure to warn consumers about unsafe drugs and devices. We’ve heard much less about lawyers who work for drug companies and try to game the regulatory system.

This latter problem was in full display this afternoon at the FDA hearing on Roche/Genentech’s appeal of the FDA’s decision to remove breast cancer from Avastin’s label.  Paul Schmidt, a Covington & Burling attorney representing Genentech, repeatedly tried to pin down FDA oncology drugs chief Richard Pazdur and his colleagues as to whether they had ever specified that replicating the progression free survival benefit seen in the first trial that led to accelerated approval would satisfy the FDA and therefore lead to permanent approval.

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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 percent of which were cardiovascular radiological or orthopedic devices — found:

Several gaps in the medical device recall process limited firms’ and FDA’s abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.

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