The Case For Avastin By Susan G Comen For the Cure

I've already linked an article on the FDA's banning of Avastin, so this link is belated, but lays out as very strong case. I came across it on http://jengriffinblog.blogspot.com/2010/12/why-we-need-to-fight-for-avastin.html

Susan G. Komen for the Cure Encourages Continued Coverage for Avastin for Breast Cancer Patients who are Benefitting from the Drug

World’s Largest Breast Cancer Organization Encourages Further Drug Development

WASHINGTON, D.C. – December 16, 2010 – Susan G. Komen for the Cure® today encouraged continued coverage for breast cancer patients benefitting from the cancer drug Avastin and the continued development of breast cancer treatments, following a U.S. Food and Drug Administration (FDA) decision to begin the process of removing approval of Avastin as a treatment for metastatic breast cancer.

The FDA’s decision today gives drug manufacturer Genentech/Roche 15 days to file an appeal for a public hearing and a process of review that could take several months. The FDA emphasized that Avastin is not being removed from the market and today’s action would not have an immediate impact on treatment for breast cancer.

The FDA cited studies that indicate Avastin did not affect overall survival of metastatic breast cancer patients and had significant side effects for many.

Komen for the Cure’s president, Elizabeth Thompson, said that the organization is concerned about the potential impact on women who are benefitting from Avastin if the FDA ultimately removes its approval for the drug for breast cancer treatment.

“We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program,” Thompson said.

“We are also urging Genentech/Roche to continue research on a biomarker for Avastin to determine which women will benefit from the drug. We are supportive of the drug development process and hope that manufacturers will continue to develop medications for the treatment of metastatic breast cancer. We will only succeed in finding new treatments for cancer by bringing new drugs to the clinic,” she said.

“As a patient advocate organization, we call on all stakeholders — government, private industry, academia and the nonprofit community — to invest in the development of biomarkers and new drugs and to get the new technology and treatments to patients’ bedsides as safely and as quickly as possible,” Thompson concluded.

Breast Cancer? The FDA BANS AVASTIN

With all the attention Breast Cancer Prevention gets you would think this decision as reported below would be unlikely. But I guess we should get used to rationing.

From Investors Business Daily: ObamaCare Rationing Begins

Medicine: The FDA has reversed its approval of a widely used cancer drug approved in Europe to treat breast cancer on the grounds it doesn't provide a "sufficient" benefit. Let the terminally ill and their doctors decide.

One of the blessings of blocking the omnibus spending bill was that it included $1 billion for the implementation of ObamaCare.

Yet the first effects are still being felt, the latest being the Food and Drug Administration's revoking of regulatory approval of Avastin to treat late-stage breast cancer.

The reason given by the FDA was that the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." What risk? These women are dying.
The drug buys them precious time, and the only risk they face is from an FDA saying "pull the plug."
On the same day the FDA channeled Dr. Kevorkian, its European counterpart, the European Medicines Agency, issued a statement approving Avastin for metastatic breast cancer.

Benefits of the drug, it said, "continue to outweigh the risks, because the available data have overwhelmingly shown to prolong progression-free survival of breast cancer patients without a negative effect on the overall survival."

So what say you, FDA? An agency overseeing the cost-conscious, government-run health care systems in the European Union says Avastin does provide sufficient benefit at little risk to the patient.

The annual cost, however, is a staggering $88,000 annually, and under ObamaCare cost trumps medical care. A prime decision is whether extending your life is worth the cost.

Consider that every year some 17,500 American women are prescribed Avastin by their practicing oncologists to treat their condition and prolong their life. Last October, the U.S. National Comprehensive Cancer Network, a group of 21 leading cancer centers that issues evidence-based medical guidelines, reaffirmed Avastin's efficacy in certain cases.

Avastin, the marketing name for the drug bevacizumab, is the world's best-selling cancer drug. Used primarily to treat colon cancer, it was first approved by the FDA in 2008 for treating breast cancer after it was found that by cutting the blood flow to tumors it slowed the progression of the disease. In some cases it has been shown to extend life as long as 20 months.

In a joint letter to the FDA and key lawmakers, two organizations — Susan G. Komen for the Cure and the Ovarian Cancer National Alliance— urge that Avastin continue to be approved for metastatic breast cancer patients and warn of the message this "decision sends about drug development for women with advanced breast cancer."

Breast cancer is the second most common cause of cancer death among American women, with 40,000 fatalities last year. Komen says the decision to use Avastin should be made between a woman and her doctor after a thoughtful consideration of the benefits and risks. We agree.

Avastin is still available on an off-label basis since it is still approved for colon, lung, kidney and brain cancer. But insurers are reluctant to cover drugs that are not FDA-approved. Medicare never does and the Centers for Medicaid and Medicare Services are now headed by Dr. Donald Berwick, to whom we and others have referred as a one-man death panel.

"The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open," Berwick has said. For some that will mean the eyes closing forever.

Berwick has also opined: "We can make a sensible social decision and say, 'Well, at this point, to have access to a particular additional benefit (new drug or medical intervention) is so expensive that our taxpayers have better use for those funds.'"

Like what? Tattoo-removal programs or Formosan subterranean termite research? This is your government, and it's here to help.