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.
Continue reading “A High Price for Rare Cancer Drugs”
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.
Continue reading “Healthcare Associated Infections: What Is The Message, and What Can We Do About Them?”
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.
Continue reading “We Will Pay For Avastin”
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.
Continue reading “Lawyers and Medical Decision-Making”