Here’s an editorial from the Wall Street Journal this morning on approval of drugs for cancer treatment; specifically Avastin for breast cancer. Yesterday the Journal had a news feature article on this controversy (not available for free online).
If the link doesn’t work the first time, try again – eventually it goes through –
A Moral Test for the FDA – WSJ.com
Some 40,000 women died from breast cancer in 2007. Almost unbelievably, the federal government may block one of the disease’s more promising therapies for no other reason than the Food and Drug Administration’s obsolete, even antimodern, regulations and approval models. Since the lives of terminally ill patients are in the balance, this is fundamentally a moral test — and one, true to type, that the FDA may well flunk.
At issue is the biologic medicine Avastin, which interferes with the growth and spread of tumors through the body by choking off their blood supply. Manufactured by Genentech, Avastin was approved for colorectal cancer in 2004 and lung cancer in 2006, and it’s been shown effective for treating recurrent or metastatic breast cancer. But in December, the FDA’s Oncologic Drugs Advisory Committee voted 5-4 against approval. The FDA is not bound by such decisions but usually follows them, and a final ruling is expected by Saturday.
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… dying patients live nearly twice as long on average before their disease gets worse, and maybe longer. It translates into an improvement in quality of life by delaying the onset of symptoms. But only in a few isolated contemporary cases has the FDA deemed progression-free survival as a relevant "end point" for approval. There’s no reason besides the FDA’s complacency and archaic procedures; a recent review by the agency’s own Science Board concluded that "evaluation methods have remained largely unchanged over the last half-century."
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… Another major culprit is political pressure from Congress, where Members know they can always get headlines by calling for a crackdown on Big Pharma or exploiting public safety anxieties. Never mind patient interest.
Patients with limited options shouldn’t be denied drugs that may improve what life they have left, even if it doesn’t extend life in the end. Thousands of breast-cancer sufferers, on the advice of their oncologists, are currently taking Avastin "off label," and an adverse FDA decision this week will make it far more difficult for them to do so. It would also be the latest moral indictment of everything that’s wrong with the FDA.
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