tag:blogger.com,1999:blog-23914463.post4831636171094689326..comments2023-10-16T09:05:15.652-07:00Comments on Professional Critic: Of The RackProfessional Critichttp://www.blogger.com/profile/08054676184824104142noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-23914463.post-42538452140204679602008-03-01T11:46:00.000-08:002008-03-01T11:46:00.000-08:00Thanks for sharing this!Thanks for sharing this!Professional Critichttps://www.blogger.com/profile/08054676184824104142noreply@blogger.comtag:blogger.com,1999:blog-23914463.post-9025992722169687652008-02-26T08:06:00.000-08:002008-02-26T08:06:00.000-08:00Melissa - so glad to hear all is benign!! I feel c...Melissa - so glad to hear all is benign!! <BR/><BR/>I feel compelled to offer another POV on Avastin (disclosure: I work at Genentech!) and the FDA...see WSJ article below.<BR/><BR/>Also, as I understand it, two members of the advisory board may have changed their votes following the second study that came out earlier this month. <BR/><BR/>S. <BR/><BR/>The Wall Street Journal (print and online) – February 21, 2008 <BR/><BR/>Opinion: A Moral Test For The FDA<BR/><BR/>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.<BR/><BR/>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.<BR/><BR/>A denial in this case would not only be unscientific but unethical. It's not as though the panel or the larger FDA bureaucracy don't recognize or acknowledge Avastin's real benefits. Rather, the FDA's lords of medicine may conclude that those benefits don't matter. And they don't matter, as the panel argued, because they don't fall into the categories that the FDA generally uses to evaluate the safety and efficacy of a drug.<BR/><BR/>In clinical trials, Avastin demonstrated the longest reported "progression-free survival" for patients with advanced breast cancer. That means they live longer before their disease spreads or worsens. An initial study submitted to the FDA showed that Avastin in combination with Taxol (another cancer therapy) delayed the growth of tumors by about 11 months – some five and half months longer than Taxol alone. Additionally, more than twice as many patients experienced significant tumor shrinkage.<BR/><BR/>In February, Genentech also released the preliminary findings of a more rigorous follow-up study, including the FDA's "gold standard" of randomized and placebo-controlled clinical trials. It again confirmed that Avastin improves progression-free survival, though the full results have not yet been made public.<BR/><BR/>In other words, 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."<BR/><BR/>Extending life is the FDA's acid test for any anticancer agent, but studies designed to prove it take years and thousands of patients to get large average effects. In the Avastin study, women lived slightly longer, a median of 26.5 months compared with 24.8 with Taxol alone. But those results weren't proved statistically significant to FDA satisfaction. Advanced therapies, however, often prove more effective among targeted populations and in some patients over others. Perhaps that's why, as the Journal's Marilyn Chase reported yesterday, even two members of the oncology panel may recant their nay votes.<BR/><BR/>At the very least, approval criteria should be broadened beyond crude mortality rates. Between the 1950s and early 1980s, when the treatments for cancer were far more limited, the FDA considered the response of tumors to treatment adequate to make judgments. Some of the most important chemotherapy drugs for cancer and autoimmune diseases gained approval during that period – cyclophosphamide, tamoxifen and others. Many are still used today, including to treat breast cancer. But it took years, sometimes decades, to learn how to use and dose them effectively once they were on the market.<BR/><BR/>No doubt thousands of lives were saved or improved by such trial and error, which is another name for medical progress. That's precisely what the FDA's bureaucratic culture, led by oncology drug chief Richard Padzur, is now obstructing. 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.<BR/><BR/>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.Anonymousnoreply@blogger.com