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.
Continue reading “On the FDA’s Decision To Withdraw Avastin’s Breast Cancer Indication”
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”.
Continue reading “More On Supplements”
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”
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.
Continue reading “Are We Seeing a Concerted Drug Industry Campaign Against the FDA?”