Thursday, July 29, 2010

Rationing Begins in Earnest in September

"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.


"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 hell 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."

Off the Big Government website

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