The FDA overruled its expert advisory panel and approved the drug Avastin for breast cancer. On his Pharmalot.com blog, Ed Silverman writes that this could mark a major shift in FDA standards for evaluating cancer drugs. He writes:
"At issue was whether slowing tumor growth - known as progression-free survival - for an additional 5-1/2 months in metastatic breast cancer merits approval, even though Avastin wasn’t shown to extend life. The question, of course, resonates far beyond any one drug as the agency grapples with increasingly vocal cancer patients and their advocates, who insist any benefit is important.For drugmakers, the approval is an important signal, because it can be expensive to conduct the lengthy trials needed to prove a drug can extend life. The approval also bolsters an industry tactic called label expansion, which is used to squeeze additional revenue out of a medication. In the case of Avastin, which is already approved to treat colon and lung cancer, Genentech may reap an additional $1.3 billion a year in revenue.
The FDA’s decision may now open the door for other cancer meds to be approved if studies find the meds can shrink tumors, although some docs worry patients may not really benefit. “If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint,” Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University, tells the Associated Press.
“The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today’s decision is a victory for drug companies, but not for patients,” Breast Cancer Action executive director Barbara Brenner says in a statement headlined ‘Patients Lose, Genentech Wins.’ "
The Wall Street Journal reports that "Avastin costs about $7,700 a month, or $84,700 for an average 11-month course for breast cancer. However, with FDA approval, Genentech will enact a $55,000-a-year price cap." And the Journal further quotes Brenner about the debate over rising prices of biotech treatments. She said, "Where we're talking about the cost of health care, biologics are the elephant in the room."
Posted by schwitz at February 23, 2008 06:59 AM | TrackBackIt is obvious that the FDA is wrapped around the fingers of the big pharmaceutical companies. They rush to approve drugs before complete testing is done and pull them later after ill effects become obvious through injury or death. Yet they tie the hands of natural herbal supplement manufacturers from making claims that their products prevent, treat or cure anything. The hypocricy is sickening and I wonder about FDA ties to drug companies that keep this power structure in place.
Posted by: karen mccarroll at February 23, 2008 09:10 AMMy policy on comments
I'm adopting the policy of a blog I admire: “Comments are great;
obnoxious comments get deleted. Deal.” I also won’t post any comment
from anyone who I consider to be pitching a product, or from anyone
who doesn’t list what appears to be an actual e-mail address.