Healthcare rationing in America is on its way, and breast cancer patients are about to be thrown under Obama's heavily-populated bus.
Read from Big Government:
ObamaCare: The Rationing Begins in Earnestby Capitol Confidential
"The ink is not yet dry on the Obama Health Care takeover and rationing advocate Donald Berkwick has yet to have his desk moved into the Medicare offices, and the Administration is already attempting to limit life-extending drugs for cancer patients.
This is the first shot in the health care revolution.
In September, the Food and Drug Administration will try to take the anti-cancer drug Avastin 'off-label.' Avastin is a Stage 4 drug used to battle breast cancer. Avastin is not a cure but has been shown to stop the growth of cancer for an average of five months — meaning some late stage breast cancer victims live beyond five months.
But late stage breast cancer patients do not fit into the cost-benefit analysis of the Obama Administration. We told America rationing would happen if the health care takeover bill passed and in September, women with breast cancer will be its first victims.
Avastin is the first medicine to fight cancer by blocking the growth of blood vessels that feed tumors. While Avastin is expensive and may not be the miracle drug some anticipated for breast cancer (it is for other types of cancer) from the success of the early trials, the overwhelming majority of breast cancer specialists believe the drug can be effective and useful in certain patients.
If the FDA takes Avastin off label it will effectively deny all but the richest Americans access to the drug. Once a drug is off label, most insurance and Medicare will no longer cover the cost of the treatment. So even if a patient meets the criteria of one who might respond positively to Avastin once it is taken off label it is highly unlikely that patient will have access to the drug unless they have the money to pay for it outright.
WHIFF OF SCANDAL?
Traditionally the FDA and ODAC make decisions based on a process called
endpoints. Does a drug achieve certain targets? In this case, the FDA changed the criteria to judge the effectiveness of the drug.
Dr. Richard Pazdur is the FDA’s Cancer Czar. Pazdur decides which anti-cancer drugs patients can have access to. In the case of Avastin, Pazdur changed the criteria to a new very subjective and slippery standard of 'clinically meaningful.' And apparently the FDA and Pazdur don’t believe that extending the life of a Breast Cancer victim by 3 to 5 months or more is 'Clinically Meaningful.'
How do you put a price tag on those precious months for the families who are living through the h*** of losing a Mother, Sister, Daughter, Aunt or Wife? Taking Avastin off label is nothing more then government rationing of healthcare. Period.
Americans with cancer live much longer than similar victims in other nations. Traditionally the FDA has not based its decisions on the cost of drug or biologic treatment, but solely on the effectiveness of the treatment. This approach seems to be changing as Obamacare is being implemented and the rationing of healthcare soon begins.
If you knew you could take a drug and perhaps live another year, would you take it? The government will now be making that decision for you.
Members of Congress should demand a briefing from the FDA/Dr. Pazdur before any action is taken to deny breast cancer patients access to treatment that may extend their lives. No one is suggesting Avastin is a perfect drug, however it has proven to be an effect treatment for some patients. We should not deny those patients access to a treatment that may extend their lives. The removal of Avastin is the Obama’s Administrations second attack on breast cancer patients, earlier this year they changed the mammography standard from 40 to 50, which could result in millions of women going undiagnosed."
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This whole story is, of course, a crock of lies. If you bothered to ever look at sources OTHER than your rightwingnut buddy bloggers, you'd find out what I did, Ms. MoreLies. One advisory panel of the FDA recommended that Avastin no longer be approved for use in breast cancer patients because, while the initial short-term study seemed to suggest that Avastin might be useful for breast cancer patients, subsequent longer term studies didn't support those findings.
If you care to read a less-biased account of what's going on with Avastin than the one you provided, Ms. MoreLies, you might start here:
http://www.boston.com/news/health/blog/2010/07/avastin_vote_ha.html
Avastin vote has limited implications, specialist says
A cancer-fighting drug based on theories advanced by the late Dr. Judah Folkman was dealt a blow this week by a federal advisory committee reviewing its use in breast cancer, but that doesn’t necessarily carry over to other cancers or other drugs in it class, a member of his Boston lab said.
A panel convened by the US Food and Drug Administration voted by a 12-to-1 margin to revoke approval of Avastin for women with late-stage breast cancer. In 2008 Avastin won accelerated approval for women with a specific type of advanced breast cancer.
Early studies had shown that women with HER-2 negative breast cancer who took Avastin and the chemotherapy drug paclitaxel (Taxol) went about five months longer without their tumors growing than women who took paclitaxel alone. The FDA’s approval was granted with the expectation of another vote once more was known from longer studies about how well it worked. Two later studies from Avastin's manufacturer did not show the same benefit as the initial one.
“What the FDA would be saying is ... for women with breast cancer, Avastin with paclitaxel was not better than paclitaxel alone. It doesn’t mean the drug wouldn’t work for other types of breast cancer or with other types of chemotherapy. Or for other types of cancer,” said Dr. Mark Kieran, who studies vascular biology in Folkman’s former lab at Children’s.
Avastin has full FDA approval for colon, lung, and kidney cancer and accelerated approval for brain cancer.
Kieran is also a pediatric neuro-oncologist at Dana-Farber Cancer Institute. He does not treat women with breast cancer, but advised caution for women wondering what to do while FDA weighs its advisory panel’s recommendation. The agency is not obligated to abide by the panel's vote, but it often does. A decision is expected by Sept. 17.
“I wouldn’t recommend that women with breast cancer stop taking their Avastin. I think this is a decision between breast oncologists and women,” once FDA makes its decision, Kieran said.
Avastin is just one drug that attacks one protein involved in angiogenesis, or the building of blood supply. There are about 40 molecules that tell the blood system to make new blood vessels, he said. Folkman pioneered the idea that tumors could be blocked by cutting off their blood vessel growth.
“This is not a blanket withdrawal of all these drugs,” Kieran said.
Genentech echoed that conclusion.
"We are disappointed by the committee's recommendation and believe Avastin should continue to be an option for women with this incurable disease," Dr. Sandra Horning, Genentech senior vice president, said in a statement Wednesday. "We will continue to discuss the data from the more than 2,400 women who participated in three Phase III studies with the FDA. This recommendation does not impact Avastin's approved uses for other cancer types."
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