Wednesday, December 21, 2005
"We believe this represents, from a medical point of view, truly a major advance," Dr. Richard Pazdur, director of the Food and Drug Administration's Office of Oncology Drug Products, said in a conference call with reporters.
The medicine is for patients with advanced renal cell carcinoma, the most common type of kidney cancer. The FDA said that in one trial, patients taking the drug went twice as long _ a median of six months versus three months for those taking a placebo _ without the cancer progressing or the patient dying.
"Rarely do we see a 100 percent improvement" in a new cancer treatment, Pazdur said, citing those figures.
When someone says they're "100% better," they're usually implying that they're back to normal. Cured, in other words. But, an improvement from three months to six months before your cancer spreads or kills you is hardly a cure. Most of us would probably cling to those extra three months if it were us - as long as we weren't feeling really sick and miserable:
About 40 percent of the patients on Nexavar had diarrhea and other gastrointestinal side effects, but FDA officials said those were generally manageable and that the drug had fewer toxic side effects than other cancer treatments.
Other side effects include rash and blisters on the palms of the hands or soles of the feet.
Those three extra months don't come cheap, either:
A month's supply of the drug will have a wholesale price of about $4,300, according to a Bayer spokeswoman. It will be available almost immediately.
That's $143 a day - wholesale. From a basic science stand-point, the drug is exciting. The first treatment in a decade to make some difference in the treatment of advanced kidney cancer. But let's be honest. It's not going to deliver a whole lot of bang for its buck. And oncologists offering it to renal cancer patients should refrain from describing it as delivering a "100% improvement."
posted by Sydney on 12/21/2005 08:47:00 PM 2 comments
I agree, its really hard not to guffaw at some of the pharmaceutical industry's claims about their drugs...I recently read Abramson's Overdosed America...if it weren't such a serious problem, it'd be really comical--the pharm. companies ridicuous claims at least merit a nutty letter from Ted Nancy.
By 9:51 PM, at
Gee, I guess you dont have metastatic renal cancer.....
By 2:50 PM, at