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Tuesday, August 31, 2010

When Protecting Women's Health Is Rationing

Some conservatives are simply beside themselves at the thought of the FDA possibly revoking Avastin for use by women with advanced breast cancer.

This is a typical standpoint for the purely reactionary group, and one that doesn't consider the implications of using a drug that has not yet been proven to be effective to the degree where it will benefit patients.

The Washington Post does a nice job at framing this from a political perspective and folding the actual health risks into nothing more than an ancillary character within it's write-up of the potential FDA decision:

Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope.

The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?

The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded....

And that is all conservatives need to have "proof" that Obama, Reid, and Pelosi are out to kill all the women in America who are unfortunate enough to be cursed with breast cancer.

However, once one takes a look at the realities of the decision to reconsider Avastin as a drug of choice for women that suffer with breast cancer, you begin to get a sense of how out of touch conservatives are with science, healthcare, and how both could possibly harm the American public.

NPR has some details to consider....

As breast cancer specialist Eric Winer at Boston's Dana-Farber Cancer Institute tells the Post, "For better or worse, Avastin has become in many ways the poster child of high-priced anti-cancer drugs."

Even if FDA goes along with the experts' advice to yank approval Avastin for breast cancer, doctors would still be able to prescribe Avastin for that use. But, and it's a big but, insurers would be less likely to approve payment if the FDA decides the evidence doesn't back up Avastin.

The Avastin case also represents a test of how FDA deals with setbacks for drugs after they've been given speedy approvals based on preliminary data. A Government Accountability Office report last year faulted the agency for not be diligent enough in following up on those actions.

FDA has the power to withdraw approval of a drug if a company hasn't performed promised studies, or they don't pan out. But as of last September, the GAO noted, the FDA "has never exercised its authority, even when such study requirements have gone unfulfilled for nearly 13 years."

The FDA is expected to make a decision on Avastin by the middle of September.

.....and while the specter of insurance company denial of paying for the drug is most certainly a talking-point generator for conservatives, the science behind the use of Avastin is being completely ignored by conservatives who are more eager to validate the "death panel" and "rationing" meme, even though the promise of Avastin use was completely destroyed with follow-up studies of the drug:

....followup studies, known as the AVADO and RIBBON-1 trials were indeed performed, and the results published. The AVADO trial was a phase III randomized double-blind clinical trial (N=736 subjects) comparing docetaxel with docetaxel plus Avastin in women with stage IV HER2-negative breast cancer. Its results were less than impressive. While it did demonstrate a decrease in PFS due to the addition of Avastin, PFS did not improve anywhere near the five months it did in the E2100 trial; rather it improved from 8.2 months to 9.0 months, a mere 0.8 month or 24 days. As in E2100, there was no detectable effect on OS. There was, however, a troubling trend towards a shorter OS in women who received Avastin. Even though the difference was not statistically significant, women who did not receive Avastin survived a median of 31.9 months; those who received the lower dose survived a median of 30.8 months; and those who received the higher dose level of Avastin survived a median of 30.2 months. In contrast to E2100, in the AVADO study Avastin did not increase the toxicity of treatment measurably.

The initial results of the RIBBON-1 trial were reported at the American Society of Clinical Oncology (ASCO) meeting last year and were similarly disappointing. In the trial, Avastin was tested in a randomized, double-blind study enrolling 1,237 patients. Oncologists could choose from capecitabine, taxane, or anthracycline-based chemotherapy, and patients would be randomized to that plus or minus Avastin. The results were that Avastin improved PFS by 2.9 months when added to capecitabine, and 1.2 months when added to anthracycline-based chemotherapy. Again, there was no improvement in OS in women receiving Avastin. In fact, it was these studies that led the FDA advisory panel to vote 12-1 to revoke FDA approval for Avastin for use in breast cancer...

While there is still no real "sure" for cancer, conservatives are treating this story of Avastin, the FDA, and the realities of science as if the Obama administration are actively trying to prevent a cancer cure from being available to women in America.

More information is available here.

So what is the conservative standpoint here?

First of all, it is apparent that the modern conservative movement is more concerned with doing away with the FDA - an agency that is responsible for ensuring that medicines are safe for men, women, and children; even conservative ones - than approaching the use of questionable medications from a scientifically reliable standpoint.

Are we to believe that conservatives of the 21st century are willing to imbibe untested and unfounded chemical cocktails in the hopes that they could possibly cure a given ailment? I'd like to see John Boehner, Steve King, or Jim DeMint take an injection of an unproven medication for whatever they are suffering from to show that they stand by their "anti-government" stance. But more than that, how about the average conservative voter? Let's take a random sampling of registered Republican voters that identify with the modern conservative movement, post those results, and then see how many would be willing to take an untested drug for something as simple as allergies and find out how many show up to the free clinic where this unknown medication will be dispensed.

I'm guessing that the turnout would be pretty low - more like none-existent.

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