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 — who come down with the disease. That’s about 10,000 patients per year in the U.S., and perhaps a similar number abroad. Multiply that times the $$115,200 a year the company plans to charge for Xalkori, and they’ve got themselves a billion dollar blockbuster.

What does it mean when a drug earns “accelerated approval”? Unfortunately, too many people think this means that it worked so well that the FDA rushed it to market. That’s not how it works. Accelerated approval, which really should be called interim approval, is reserved for drugs that show promise for treating life-threatening diseases like lung cancer, which is the best way to describe Xalkori.

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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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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 about 100,000 people a year, and add $35 billion a year to our collective health care bill (here in the US of A); 5% of hospital inpatients end up with an HAI.

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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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